A clinical trial is a research study involving human volunteers, and is designed to answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find effective treatments, and new ways to improve health.
You can search for all studies that are currently enrolling participants at the University of Rochester by typing in keywords in the search box below. If you don’t find a study that interests you right now, consider signing up for our Volunteer Registry, which will notify you of future studies.
*A151216 ALCHEMIST Screening Protocol
Lead Researcher: Yuhchyau Chen
This ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA
non-small cell lung cancer that has been or will be removed by surgery. Studying the
genes in a patient's tumor cells may help doctors select the best treatment for patients
that have certain genetic changes.
View Study Details
*EA2182 / RGIC19164 / DECREASE / Haoming Qiu
Lead Researcher: Haoming Qiu
This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation)
therapy works in comparison to standard-dose chemoradiation in treating patients with
early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil,
and capecitabine, work in different ways to stop the growth of tumor cells, either
by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving
chemotherapy with radiation therapy may kill more tumor cells. This study may help
doctors find out if lower-dose chemoradiation is as effective and has fewer side effects
than standard-dose chemoradiation, which is the usual approach for treatment of this
cancer type.
View Study Details
*NRG-CC009 / CRLUN22012 / Milano
Lead Researcher: Michael Milano
This phase III trial compares the effect of stereotactic radiosurgery to standard
of care memantine and whole brain radiation therapy that avoids the hippocampus (the
memory zone of the brain) for the treatment of small cell lung cancer that has spread
to the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers
a single, high dose of radiation directly to the tumor and may cause less damage to
normal tissue. Whole brain radiation therapy delivers a low dose of radiation to the
entire brain including the normal brain tissue. Hippocampal avoidance during whole-brain
radiation therapy (HA-WBRT) decreases the amount of radiation that is delivered to
the hippocampus which is a brain structure that is important for memory. The drug,
memantine, is also often given with whole brain radiotherapy because it may decrease
the risk of side effects related to thinking and memory. Stereotactic radiosurgery
may decrease side effects related to memory and thinking compared to standard of care
HA-WBRT plus memantine.
View Study Details
*NRG-GU011 PROMETHEAN / RGUP21115 / Zhang
Lead Researcher: Hong Zhang
This phase II trial tests whether relugolix and radiation therapy works to shrink
tumors in patients with prostate cancer that has spread in a limited way to 1 to 5
other parts of the body (oligometastatic). Testosterone can cause the growth of prostate
cancer cells. Relugolix lowers the amount of testosterone made by the body. This may
help stop the growth of tumor cells that need testosterone to grow. Giving relugolix
with radiation therapy may help lower the chance of prostate cancer growing or spreading.
View Study Details
*RTOG 1216 / RHAN13055 / Surgery and Postoperative Radiation / Yuhchyau Chen
Lead Researcher: Yuhchyau Chen
This phase II/III trial studies how well radiation therapy works when given together
with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating
patients with high-risk stage III-IV head and neck cancer the begins in the thin,
flat cells (squamous cell). Specialized radiation therapy that delivers a high dose
of radiation directly to the tumor may kill more tumor cells and cause less damage
to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work
in different ways to stop the growth of tumor cells, either by killing the cells or
by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere
with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal
antibodies, such as atezolizumab, may help the body's immune system attack the cancer,
and may interfere with the ability of tumor cells to grow and spread. The purpose
of this study is to compare the usual treatment (radiation therapy with cisplatin
chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy,
and using the usual treatment plus an immunotherapy drug, atezolizumab.
View Study Details
A022101 ERASur / CRGIC23031 / Alliance / QIU
Lead Researcher: Haoming Qiu
This phase III trial compares total ablative therapy and usual systemic therapy to
usual systemic therapy alone in treating patients with colorectal cancer that has
spread to up to 4 body sites (limited metastatic). The usual approach for patients
who are not participating in a study is treatment with intravenous (IV) (through a
vein) and/or oral medications (systemic therapy) to help stop the cancer sites from
getting larger and the spread of the cancer to additional body sites. Ablative means
that the intention of the local treatment is to eliminate the cancer at that metastatic
site. The ablative local therapy will consist of very focused, intensive radiotherapy
called stereotactic ablative radiotherapy (SABR) with or without surgical resection
and/or microwave ablation, which is a procedure where a needle is temporarily inserted
in the tumor and heat is used to destroy the cancer cells. SABR, surgical resection,
and microwave ablation have been tested for safety, but it is not scientifically proven
that the addition of these treatments are beneficial for your stage of cancer. The
addition of ablative local therapy to all known metastatic sites to the usual approach
of systemic therapy could shrink or remove the tumor(s) or prevent the tumor(s) from
returning.
View Study Details
A041703 / CLEU19006 / O'Dwyer, Kristen
Lead Researcher: Kristen O'Dwyer
This phase II trial studies how well inotuzumab ozogamicin and blinatumomab work in
treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is
newly diagnosed, has come back, or does not respond to treatment. Immunotherapy with
monoclonal antibodies, such as inotuzumab ozogamicin and blinatumomab, may help the
body's immune system attack the cancer, and may interfere with the ability of tumor
cells to grow and spread.
View Study Details
A081801 / RLUN20119 / ALCHEMIST-IO (ACCIO) / Yuhchyau Chen
Lead Researcher: Yuhchyau Chen
This phase III ALCHEMIST trial tests the addition of pembrolizumab to usual chemotherapy
for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that
has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab,
may help the body's immune system attack the cancer, and may interfere with the ability
of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, pemetrexed,
carboplatin, gemcitabine hydrochloride, and paclitaxel, work in different ways to
stop the growth of tumor cells, either by killing the cells, by stopping them from
dividing, or by stopping them from spreading. Giving pembrolizumab with usual chemotherapy
may help increase survival times in patients with stage IIA, IIB, IIIA or IIIB non-small
cell lung cancer.
View Study Details
Adapting CBT-I for Hazardous Alcohol Users
Lead Researcher: Wilfred Pigeon
The goal of this intervention development trial is to develop, refine, and test a
telephone-delivered, 4-session version of cognitive behavioral therapy for insomnia
adapted
to hazardous alcohol users with co-occurring insomnia. The project will begin with
a small,
open label pilot to refine the intervention and proceed to a small, randomized trial
comparing the intervention to a sleep and alcohol education control condition.
The two main questions it aims to answer are whether the intervention is feasible
to deliver
and whether its effects on alcohol use and insomnia severity are large enough to warrant
further work.
View Study Details
ADVANCED-2
Lead Researcher: William Tabayoyong
TARA-002-101-Ph2 is an open-label study to investigate the safety and anti-tumor activity
of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade
CIS NMIBC (± Ta/T1).
The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety
and anti-tumor activity of TARA-002 at the RP2D which has been established in the
Phase 1a dose finding study (TARA-002-101-Ph1a).
This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease
(defined as disease present at last tumor evaluation prior to signing ICF).
Participants will be enrolled into one of 2 cohorts:
Cohort A:
* Participants with CIS (± Ta/T1) who are BCG naive, or
* Participants with CIS (± Ta/T1) who are BCG exposed and have not received intravesical
BCG for at least 24 months prior to the most recent CIS diagnosis
Cohort B:
* Participants with persistent or recurrent CIS (± Ta/T1) who are BCG unresponsive
within 12 months of completion of adequate BCG therapy (minimum 5/6 doses induction
and 2/3 doses maintenance or 2/6 doses reinduction)
View Study Details
Algo TX/IOCPC23007/ Gewandter
Lead Researcher: Jennifer Gewandter
The purpose of this clinical trial is to compare the efficacy of twice daily applications
of ATX01 (10% \& 15%) versus placebo during a 12-week treatment period in treating
chemotherapy-induced peripheral neuropathy (CIPN) in adult cancer survivor patients.
View Study Details
An EEG Study of Auditory Perception in People with and without Schizophrenia
Lead Researcher: Judy Thompson
The purpose of our study is to better understand how the brain processes sounds, including
speech. We are investigating this in people with and without psychiatric conditions.
One of our primary aims is to determine how these processes may relate to specific
experiences and symptoms in conditions such as schizophrenia, schizoaffective disorder,
and schizophreniform disorder, with the goal of using this knowledge to develop more
effective treatments. In order to study how the brain processes sounds, we use a technique
called electroencephalography, or EEG. For EEG, a person wears a comfortable elastic
cap with sensors attached to it that are able to record brain activity. In these sessions,
subjects listen to short audio clips while EEG is recording; this allows us to measure
brain responses to sounds. This study also includes interviews about current and past
psychiatric symptoms and treatment, as well as a few short tasks, questionnaires,
and a hearing test. The study typically involves 4-5 visits, with each about 2-3 hours
long. Subjects are paid $30 an hour, as well as a $30 bonus if they complete all study
activities. Transportation costs are also covered, and free snacks are provided. People
between the ages of 18-55 with a diagnosis of schizophrenia, schizoaffective disorder,
schizophreniform disorder, or no psychiatric diagnosis may be eligible to participate.
View Study Details
Assessment of Patients with Brain Tumors, Ages 65+
Lead Researcher: Andrea Wasilewski
The purpose of this study is to collect information about the physical function,
thinking, independence, social support, and medications of older patients with brain
tumors in order to develop more specialized treatments and support for that
population. Inclusion Criteria: Age 65 or older of any race, ethnicity, or gender;
Pathologically confirmed glioblastoma or anaplastic astrocytoma; Have not started
radiation or chemotherapy for brain tumor treatment
View Study Details
Atorvastatin Study in HNSCC/UHAN21082/Newlands
Lead Researcher: Shawn Newlands
Background:
Cisplatin is used to treat head and neck cancer. People who take this drug are at
risk for hearing loss. Atorvastatin is a drug used to treat high cholesterol. It might
reduce the risk of cisplatin-induced hearing loss.
Objective:
To find out if atorvastatin reduces hearing loss in people treated with cisplatin
and radiation.
Eligibility:
People ages 18 and older with squamous cell carcinoma of the head and neck who will
undergo treatment with cisplatin-based chemotherapy and radiation
Design:
Participants will be screened with their medical records.
Participants currently taking a cholesterol-lowering statin medication are invited
to participate in the observational arm of the study. Those not taking such a medication
are invited to participate in the interventional arm of the study.
All participants will have 3 study visits for the purpose of evaluating hearing. One
before starting cisplatin treatment, one within 3 months of completing cancer treatment,
and one within 2 years of completing cancer treatment. They will have tympanograms.
A small flexible tip will be placed in the ear canal. A puff of air will be delivered
to assess mobility of the ear drum. They will have hearing tests. They will wear headphones.
They will listen to tones that vary in loudness. They will be asked to indicate when
they hear a sound. They will complete 3 questionnaires at the time of each hearing
test.
Participants will have 2 visits for blood tests. These will occur upon consent and
12 weeks after. They will be randomly assigned to take the study drug or placebo orally,
once daily. They will take it during cisplatin treatment and for 3 months after treatment.
Long-term follow up will include a chart review 2 years after participants complete
their cisplatin therapy.
View Study Details
BABE
Lead Researcher: Kirsi Jarvinen-seppo
You are eligible if you are pregnant and 18 years old or older and give birth to a
healthy infant.
The purpose of this study is to compare a group of people at low risk for getting
allergies, the Old Order Mennonite, with a group of people at higher risk of getting
allergies, the average person living in Rochester. The immune system protects us from
diseases, working throughout the body, including in secretions such as saliva and
breast milk, and in the normal bacteria in the stomach and intestines. The way people
live, including the things they are exposed to, changes the way the immune system
develops. A baby’s immune system develops over time. The baby’s ability to fight disease
is helped by the mom’s immunity passed to the baby through breast milk. By comparing
biological samples like saliva, breast milk, and stool, we can study differences between
these two groups to see what’s different in a group at low risk and a group at higher
risk of getting allergies. Using questionnaires and biologic samples (stool, skin
cells, blood, etc.) we will evaluate the development of the infant microbiome, metabolite
composition and the immune system and how that relates to the development of allergic
disease. The microbiome is the collection of all microbes, such as bacteria, fungi,
viruses, and their genes, that naturally live on our bodies and inside us. A metabolite
is any substance produced during metabolism (digestion or other bodily chemical processes).
The term metabolite may also refer to the product that remains after a medicine is
broken down (metabolized) by the body.
View Study Details
BEGIN - A Breastfeeding Study
Lead Researcher: Bridget Young
We are looking for:
- Mothers who are exclusively pumping for babies under 5 weeks old
- Participation will last until your baby is 5 months old
- We will have you collect breastmilk, stool, urine, and saliva at home
- This study is totally remote – no need to ever leave your house!
Earn $100/month & receive breastfeeding support from our team!
View Study Details
CBMT11074 / NMDP 10-CBA / Omar Aljitawi, MBBS (previous PI-Jane Liesveld, MD)
Lead Researcher: Omar Aljitawi
This study is an access and distribution protocol for unlicensed cryopreserved cord
blood units (CBUs) in pediatric and adult patients with hematologic malignancies and
other indications.
View Study Details
CBRS21001 / A011801 / Dhakal
Lead Researcher: Ajay Dhakal
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib
work in preventing breast cancer from coming back (relapsing) in patients with high
risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab,
linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy
because it attaches to specific molecules (receptors) on the surface of cancer cells,
known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth
of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1
and tucatinib may work better in preventing breast cancer from relapsing in patients
with HER2 positive breast cancer compared to T-DM1 alone.
View Study Details
CBRT20074 / A071701 / NImish Mohile
Lead Researcher: Nimish Mohile
This phase II trial studies how well genetic testing works in guiding treatment for
patients with solid tumors that have spread to the brain. Several genes have been
found to be altered or mutated in brain metastases such as NTRK, ROS1, CDK, PI3K,
or KRAS G12C. Medications that target these genes such as abemaciclib, paxalisib,
entrectinib and adagrasib may stop the growth of tumor cells by blocking some of the
enzymes needed for cell growth. Genetic testing may help doctors tailor treatment
for each mutation.
View Study Details
CCTG-MA.39 TAILOR RT / CRBRS23092 / Gergelis
Lead Researcher: Kimberly Gergelis
The purpose of this study is to compare the effects on low risk breast cancer receiving
usual care that includes regional radiation therapy, with receiving no regional radiation
therapy. Researchers want to see if not giving this type of radiation treatment works
as well at preventing breast cancer from coming back.
View Study Details
Cedars - Sinai - Gross Hematuria - UGUB23025
Lead Researcher: Edward Messing
To improve upon the non-invasive detection of BCa by further validating a multiplex
ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples
of patients with gross hematuria.
View Study Details
CGIP20087 / A021806 / Richard Dunne
Lead Researcher: Daniel Mulkerin
This phase III trial compares perioperative chemotherapy (given before and after surgery)
versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic
cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs,
such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, work in different ways
to stop the growth of tumor cells, either by killing the cells, by stopping them from
dividing, or by stopping them from spreading. Giving chemotherapy before and after
surgery (perioperatively) may work better in treating patients with pancreatic cancer
compared to giving chemotherapy after surgery (adjuvantly).
View Study Details
CGUK20147 / S1931 / Frye
Lead Researcher: Thomas Frye
This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based
drug combination versus a standard of care immunotherapy-based drug combination alone
in treating patients with kidney cancer that has spread to other places in the body
(metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab,
pembrolizumab, and avelumab, may help the body's immune system attack the cancer,
and may interfere with the ability of tumor cells to grow and spread. Axitinib may
stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Surgery to remove the kidney, called a nephrectomy, is also considered standard of
care; however, doctors who treat kidney cancer do not agree on its benefits. It is
not yet known if the addition of surgery to an immunotherapy-based drug combination
works better than an immunotherapy-based drug combination alone in treating patients
with kidney cancer.
View Study Details
CGUP18150 / S1802 / Chunkit Fung
Lead Researcher: Chunkit Fung
This phase III trial studies how well standard systemic therapy with or without definitive
treatment (prostate removal surgery or radiation therapy) works in treating participants
with prostate cancer that has spread to other places in the body. Addition of prostate
removal surgery or radiation therapy to standard systemic therapy for prostate cancer
may lower the chance of the cancer growing or spreading.
View Study Details
CGYM19142 / NRG-GY019 / Richard Moore
Lead Researcher: Richard Moore
This phase III trial studies how well letrozole with or without paclitaxel and carboplatin
works in treating patients with stage II-IV low-grade serous carcinoma of the ovary,
fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount
of estrogen made by the body which in turn may stop the growth of tumor cells that
need estrogen to grow. Drugs used in chemotherapy, such as paclitaxel and carboplatin,
work in different ways to stop the growth of tumor cells, either by killing the cells,
by stopping them from dividing, or by stopping them from spreading. It is not yet
known whether giving letrozole alone or in combination with paclitaxel and carboplatin
works better in treating patients with low-grade serous carcinoma of the ovary, fallopian
tube, or peritoneum compared to paclitaxel and carboplatin without letrozole.
View Study Details
CGYO20085 / NRG-CC008 / Richard Moore
Lead Researcher: Richard Moore
This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy
and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for
individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal
of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal
of both the fallopian tubes and ovaries. This study may help doctors determine if
the two surgical procedures are nearly the same for ovarian cancer risk reduction
for women with BRCA1 mutations.
View Study Details
CHAN21104 / NRG-HN009 / Patel
Lead Researcher: Arpan Patel
This phase II/III trial compares the effect of the combination of high-dose cisplatin
every three weeks and radiation therapy versus low-dose cisplatin weekly and radiation
therapy for the treatment of patients with locoregionally advanced head and neck cancer.
Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of
tumor cells, either by killing the cells, by stopping them from dividing, or by stopping
them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells
and shrink tumors. This study is being done to find out if low-dose cisplatin given
weekly together with radiation therapy is the same or better than high-dose cisplatin
given every 3 weeks together with radiation therapy in treating patients with head
and neck cancer.
View Study Details
CLEU20105/ S1905/ Kristen O'Dwyer
Lead Researcher: Kristen O'Dwyer
This phase II trial studies how well OBI-3424 works in treating patients with T-cell
acute lymphoblastic leukemia that has come back (relapsed) or does not response to
treatment (refractory). Drugs used in chemotherapy, such as OBI-3424, work in different
ways to stop the growth of cancer cells, either by killing the cells, by stopping
them from dividing, or by stopping them from spreading. OBI-3424 may reduce the amount
of leukemia in the body.
View Study Details
CLEU20136 / EA9181 / O'Dwyer
Lead Researcher: Kristen O'Dwyer
This phase III trial compares the effect of usual treatment of chemotherapy and steroids
and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab
is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer
cells to grow and spread. The information gained from this study may help researchers
determine if combination therapy with steroids, TKIs, and blinatumomab work better
than the standard of care.
View Study Details
CLUN19026 / LUNGMAP / Megan Baumgart
Lead Researcher: Megan Baumgart
This screening and multi-sub-study randomized phase II/III trial will establish a
method for genomic screening of similar large cancer populations followed by assigning
and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP).
The type of cancer trait (biomarker) will determine to which sub-study, within this
protocol, a participant will be assigned to compare new targeted cancer therapy, designed
to block the growth and spread of cancer, or combinations to standard of care therapy
with the ultimate goal of being able to approve new targeted therapies in this setting.
In addition, the protocol includes non-match sub-studies which will include all screened
patients not eligible for any of the biomarker-driven sub-studies.
View Study Details
CLUN21035 / S1900E / Baumgart
Lead Researcher: Megan Baumgart
This phase II Lung-MAP treatment trial studies the effect of AMG 510 in treating non-squamous
non-small cell lung cancer that is stage IV or has come back (recurrent) and has a
specific mutation in the KRAS gene, known as KRAS G12C. Mutations in this gene may
cause the cancer to grow. AMG 510, a targeted treatment against the KRAS G12C mutation,
may help stop the growth of tumor cells.
View Study Details
CLYM20151 / S1925 / Barr
Lead Researcher: Paul Barr
This phase III trial compares early treatment with venetoclax and obinutuzumab versus
delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed
high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax is
in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop
the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival.
Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's
immune system attack the cancer, and may interfere with the ability of tumor cells
to grow and spread. Starting treatment with the venetoclax and obinutuzumab early
(before patients have symptoms) may have better outcomes for patients with chronic
lymphocytic leukemia or small lymphocytic lymphoma compared to starting treatment
with the venetoclax and obinutuzumab after patients show symptoms.
View Study Details
CLYM21071 / S2005 / Zent
Lead Researcher: Clive Zent
This phase II trial studies the effects of venetoclax and rituximab in comparison
to ibrutinib and rituximab in treating patients with previously untreated Waldenstrom's
macroglobulinemia/lymphoplasmacytic lymphoma. Ibrutinib may stop the growth of cancer
cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal
antibody. It binds to a protein called CD20, which is found on B cells (a type of
white blood cell) and some types of cancer cells. This may help the immune system
kill cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2
(BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein
needed for cancer cell survival. Giving venetoclax and rituximab may work better in
treating patients with previously untreated Waldenstrom's macroglobulinemia than ibrutinib
and rituximab alone.
View Study Details
CLYM21085 / A051902 / Casulo
Lead Researcher: Carla Casulo
This phase II trial studies the effect of duvelisib or CC-486 and usual chemotherapy
consisting of cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone
in treating patients with peripheral T-cell lymphoma. Duvelisib may stop the growth
of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy
drugs, such as CC-486, cyclophosphamide, doxorubicin, vincristine, etoposide and prednisone,
work in different ways to stop the growth of cancer cells, either by killing the cells,
by stopping them from dividing, or by stopping them from spreading. This trial may
help find out if this approach is better or worse than the usual approach for treating
peripheral T-cell lymphoma.
View Study Details
CLYM21088 / ANHL1931 / Casulo
Lead Researcher: Carla Casulo
This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus
chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal
B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab,
may help the body's immune system attack the cancer, and may interfere with the ability
of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined
with an immunotherapy called rituximab. Chemotherapy drugs work in different ways
to stop the growth of cancer cells, either by killing the cells, by stopping them
from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody.
It binds to a protein called CD20, which is found on B cells (a type of white blood
cell) and some types of cancer cells. This may help the immune system kill cancer
cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.
View Study Details
CMBRS23057 / Weiss / A012103
Lead Researcher: Anna Weiss
The phase III trial compares the effect of pembrolizumab to observation for the treatment
of patients with early-stage triple-negative breast cancer who achieved a pathologic
complete response after preoperative chemotherapy in combination with pembrolizumab.
Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's
immune system attack the cancer, and may interfere with the ability of tumor cells
to grow and spread. This trial may help researchers determine if observation will
result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative
breast cancer patients who achieve pathologic complete response after preoperative
chemotherapy with pembrolizumab.
View Study Details
CMBRS24006 / Falkson / NRG-BR009
Lead Researcher: Carla Falkson
This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian
function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET
in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early-
stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative
tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25
(for pN1 patients).
View Study Details
CMGIC22093 // A022104 // BADRI
Lead Researcher: Nabeel Badri
This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course
chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy
drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin),
FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin
and oxaliplatin) work in different ways to stop the growth of tumor cells, either
by killing the cells, by stopping them from dividing, or by stopping them from spreading.
FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer.
Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to
higher rates of clinical complete response (with a chance of avoiding surgery) compared
to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.
View Study Details
CMGIC23011 // NRG-GI008 // McGreevy
Lead Researcher: Maria McGreevy
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to
patients based on the presence or absences of circulating tumor DNA (ctDNA) after
surgery for colon cancer.
View Study Details
CMGUB24000 // A031701 // GUERCIO
Lead Researcher: Brendan Guercio
This phase II trial studies how well gemcitabine hydrochloride and cisplatin work
in treating participants with invasive bladder urothelial cancer. Drugs used in chemotherapy,
such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the
growth of tumor cells, either by killing the cells, by stopping them from dividing,
or by stopping them from spreading.
View Study Details
CMGYN23039_Moore_NRG-GY025
Lead Researcher: Richard Moore
This phase II trial tests whether the combination of nivolumab and ipilimumab is better
than nivolumab alone to shrink tumors in patients with deficient mismatch repair system
(dMMR) endometrial carcinoma that has come back after a period of time during which
the cancer could not be detected (recurrent). Deoxyribonucleic acid (DNA) mismatch
repair (MMR) is a system for recognizing and repairing damaged DNA. In 2-3% of endometrial
cancers this may be due to a hereditary condition resulted from gene mutation called
Lynch Syndrome (previously called hereditary nonpolyposis colorectal cancer or HNPCC).
MMR deficient cells usually have many DNA mutations. Tumors that have evidence of
mismatch repair deficiency tend to be more sensitive to immunotherapy. There is some
evidence that nivolumab with ipilimumab can shrink or stabilize cancers with deficient
mismatch repair system. However, it is not known whether this will happen in endometrial
cancer; therefore, this study is designed to answer that question. Monoclonal antibodies,
such as nivolumab and ipilimumab, may help the body's immune system attack the cancer,
and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab
in combination with ipilimumab may be better than nivolumab alone in treating dMMR
recurrent endometrial carcinoma.
View Study Details
CMLEU23033 // A042001 // O'Dwyer
Lead Researcher: Kristen O'Dwyer
This phase II trial compares the combination of inotuzumab ozogamicin and chemotherapy
to the usual chemotherapy in treating patients with B-cell acute lymphoblastic leukemia
or B-cell lymphoblastic lymphoma. Inotuzumab ozogamicin is a monoclonal antibody,
called inotuzumab, linked to a drug, called CalichDMH. Inotuzumab is a form of targeted
therapy because it attaches to specific molecules (receptors) on the surface of cancer
cells, known as CD22 receptors, and delivers CalichDMH to kill them. Chemotherapy
drugs work in different ways to stop the growth of cancer cells, either by killing
the cells, by stopping them from dividing, or by stopping them from spreading. Giving
inotuzumab ozogamicin with chemotherapy may help shrink the cancer and stop it from
returning.
View Study Details
CMLUN23010 // S2302 // MULFORD
Lead Researcher: Deborah Mulford
This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab
versus standard of care chemotherapy for the treatment of non-small cell lung cancer
that is stage IV or that has come back after a period of improvement (recurrent).
Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels
that tumors need to grow. Immunotherapy with monoclonal antibodies, such as pembrolizumab,
may help the body's immune system attack the cancer, and may interfere with the ability
of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop
the growth of tumor cells, either by killing the cells, by stopping them from dividing,
or by stopping them from spreading. This trial may help doctors find out if giving
ramucirumab with pembrolizumab is more effective at treating patients with stage IV
or recurrent non-small cell lung cancer than standard chemotherapy.
View Study Details
CMLUN24013 // EA5221 // Baumgart
Lead Researcher: Megan Baumgart
This phase III trial compares the effect of adding chemotherapy to immunotherapy (pembrolizumab)
versus immunotherapy alone in treating patients with stage IIIB-IV lung cancer. Immunotherapy
with monoclonal antibodies, such as pembrolizumab, may help the body's immune system
attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Chemotherapy drugs work in different ways to stop the growth of tumor cells, either
by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Giving pembrolizumab and chemotherapy may help stabilize lung cancer.
View Study Details
CMLYM23020 // S2114 // Reagan
Lead Researcher: Patrick Reagan
This phase II trial tests whether mosunetuzumab and/or polatuzumab vedotin helps benefit
patients who have received chemotherapy (fludarabine and cyclophosphamide) followed
by chimeric antigen receptor (CAR) T-cell therapy (tisagenlecleucel, axicabtagene
ciloleucel, or lisocabtagene maraleucel) for diffuse large B-cell lymphoma that has
come back (recurrent) or that does not respond to treatment (refractory) or grade
IIIb follicular lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere
with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal
antibody, called polatuzumab, linked to a drug called vedotin. Polatuzumab is a form
of targeted therapy because it attaches to specific molecules (receptors) on the surface
of cancer cells, and delivers vedotin to kill them. Chemotherapy drugs, such as fludarabine
and cyclophosphamide, work in different ways to stop the growth of cancer cells, either
by killing the cells, by stopping them from dividing, or by stopping them from spreading.
CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of
immune system cell) are changed in the laboratory so they will attack cancer cells.
T cells are taken from a patient's blood. Then the gene for a special receptor that
binds to a certain protein on the patient's cancer cells is added to the T cells in
the laboratory. The special receptor is called a chimeric antigen receptor. Large
numbers of the CAR T cells are grown in the laboratory and given to the patient by
infusion for treatment of certain cancers. Giving mosunetuzumab and/or polatuzumab
vedotin after chemotherapy and CAR T-cell therapy may be more effective at controlling
or shrinking the cancer than not giving them.
View Study Details
CMLYM23030 // AHOD2131 // Casulo
Lead Researcher: Carla Casulo
This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin
and nivolumab) to standard treatment (chemotherapy with or without radiation) to the
standard treatment alone in improving survival in patients with stage I and II classical
Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug
conjugates. It is made of a monoclonal antibody called brentuximab that is linked
to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma
cells in a targeted way and delivers vedotin to kill them. A monoclonal antibody is
a type of protein that can bind to certain targets in the body, such as molecules
that cause the body to make an immune response (antigens). Immunotherapy with monoclonal
antibodies, such as nivolumab, may help the body's immune system attack the cancer,
and may interfere with the ability of tumor cells to grow and spread. Chemotherapy
drugs such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine,
and procarbazine hydrochloride work in different ways to stop the growth of cancer
cells, either by killing the cells, by stopping them from dividing, or by stopping
them from spreading. Cyclophosphamide is in a class of medications called alkylating
agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer
cells. It may also lower the body's immune response. Etoposide is in a class of medications
known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division
and DNA repair and may kill cancer cells. Vincristine is in a class of medications
called vinca alkaloids. It works by stopping cancer cells from growing and dividing
and may kill them. Prednisone is in a class of medications called corticosteroids.
It is used to reduce inflammation and lower the body's immune response to help lessen
the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays
to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment
of chemotherapy with or without radiation may increase survival and/or fewer short-term
or long-term side effects in patients with classical Hodgkin lymphoma compared to
the standard treatment alone.
View Study Details
CMLYM23075 // A052101 // Wallace
Lead Researcher: Danielle Wallace
This phase III trial tests whether continuous or intermittent zanubrutinib after achieving
a complete remission (CR) with rituximab works in older adult patients with mantle
cell lymphoma (MCL) who have not received treatment in the past (previously untreated).
Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells
to grow and spread. Zanubrutinib may stop the growth of cancer cells by blocking some
of the enzymes needed for cell growth. When zanubrutinib is used in MCL, the current
standard of care is to continue administering the drug indefinitely until disease
progression. This continuous treatment comes with clinical as well as financial toxicity,
which could be especially detrimental in older patients. For patients who achieve
a CR after initial zanubrutinib plus rituximab therapy, it may be safe and equally
effective to stop treatment and restart zanubrutinib upon disease progression rather
than continuing indefinitely in previously untreated older adult patients with MCL.
View Study Details
CMMEL22099_Galka_S2015
Lead Researcher: Eva Galka
Patients with a primary invasive melanoma are recommended to undergo excision of the
primary lesion with a wide margin. There is evidence that less radical margins of
excision may be just as safe. This is a randomised controlled trial of 1 cm versus
2 cm margin of excision of the primary lesion for adult patients with stage II primary
invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free
survival. A reduction in margins is expected to improve patient quality of life.
View Study Details
CMMMY23044 // S2209 // Lipe
Lead Researcher: Brea Lipe
This phase III trial compares three-drug induction regimens followed by double-or
single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma
in patients who are not receiving a stem cell transplant and are considered frail
or intermediate-fit based on age, comorbidities, and functional status. Treatment
for multiple myeloma includes initial treatment (induction) which is the first treatment
a patient receives for cancer followed by ongoing treatment (maintenance) which is
given after initial treatment to help keep the cancer from coming back. There are
three combinations of four different drugs being studied. Bortezomib is one of the
drugs that may stop the growth of cancer cells by blocking some of the enzymes needed
for cell growth. Lenalidomide works by helping bone marrow to produce normal blood
cells and killing cancer cells. Anti-inflammatory drugs, such as dexamethasone, lower
the body's immune response and are used with other drugs in the treatment of some
types of cancer. Daratumumab and hyaluronidase-fihj is a monoclonal antibody that
may interfere with the ability of cancer cells to grow and spread. Patients receive
1 of 3 combinations of these drugs for treatment to determine which combination of
study drugs works better to shrink and control multiple myeloma.
View Study Details
CMMY19113 / S1803 / Brea Lipe
Lead Researcher: Brea Lipe
Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to
Reg Step 2. Patients are followed until they will begin Maintenance and then registered
to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide
for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance,
MRD is assessed to guide further therapy. MRD-positive patients will continue with
the assigned treatment. MRD-negative patients will be further randomized (Reg Step
3) to either continue or discontinue the assigned treatment. Patients are treated
for up to 7 years from Step 2 reg and followed for up to 15 years.
View Study Details
CMSAR23088 // EA7211 // Victor
Lead Researcher: Adrienne Victor
This is a multicenter, randomized, open label phase lll trial to assess whether preoperative
chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of
high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as
measured by disease free survival.
After confirmation of eligibility criteria, patients will be randomized to either
the standard arm or experimental arm.
View Study Details
Connection in Caregivers
Lead Researcher: Kimberly Van orden
Subjects will complete a baseline interview (phone/zoom and online) at the beginning
of the study. If eligible, subjects will complete 10 days of surveys that are texted
3 times a day (morning, afternoon, evening). Eligible subjects will also complete
a follow-up interview (zoom/phone and online) at 6 months. Subjects are paid up to
$400 for completing assessments. Inclusion: age 50 and older; caring daily for a
loved one with dementia; caregiving stress. Exclusion: Under 50 years of age; not
caring for a loved one with dementia daily.
View Study Details
COVID-19 Vaccine Studies
Lead Researcher: Ann Falsey
URMC is studying several variations of a COVID-19 vaccine. Compensation: $500-$900.
Participation Requirements: Age 18+; Have not been infected with COVID-19. To volunteer,
take our survey to find out if you qualify: https://redcap.urmc.rochester.edu/redcap/surveys/?s=XHH9MC8RMK
View Study Details
CPLEU23006 // ASCT2031 // Andolina
Lead Researcher: Jeffrey Andolina
This phase III trial compares hematopoietic (stem) cell transplantation (HCT) using
mismatched related donors (haploidentical \[haplo\]) versus matched unrelated donors
(MUD) in treating children, adolescents, and young adults with acute leukemia or myelodysplastic
syndrome (MDS). HCT is considered standard of care treatment for patients with high-risk
acute leukemia and MDS. In HCT, patients are given very high doses of chemotherapy
and/or radiation therapy, which is intended to kill cancer cells that may be resistant
to more standard doses of chemotherapy; unfortunately, this also destroys the normal
cells in the bone marrow, including stem cells. After the treatment, patients must
have a healthy supply of stem cells reintroduced or transplanted. The transplanted
cells then reestablish the blood cell production process in the bone marrow. The healthy
stem cells may come from the blood or bone marrow of a related or unrelated donor.
If patients do not have a matched related donor, doctors do not know what the next
best donor choice is. This trial may help researchers understand whether a haplo related
donor or a MUD HCT for children with acute leukemia or MDS is better or if there is
no difference at all.
View Study Details
CPSAR23078 / Kazi / ARST2032
Lead Researcher: Rafi Kazi
Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body.
This phase III trial aims to maintain excellent outcomes in patients with very low
risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment
with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized
molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of
the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS)
respond to standard chemotherapy when patients with VLR-RMS and patients who have
rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines
the effect of therapy intensification in patients who have RMS cancer with DNA mutations
to see if their outcomes can be improved.
View Study Details
Developing a collection of clinical, imaging and biologic specimens to identify biological
markers of Parkinson’s risk, onset and progression
Lead Researcher: Ruth Schneider
The Parkinson Progression Marker Initiative 2.0 (PPMI 2.0) is a longitudinal, observational,
multi-center natural history study to assess progression of clinical features, digital
outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression
in study participants with manifest PD, prodromal PD, and healthy controls.
The overall goal of the study is to identify markers of disease progression for use
in
clinical trials of therapies to reduce progression of PD disability.
View Study Details
DRO2005 / RHAN20083 / ALTENS / Michael Cummings
Lead Researcher: Michael Cummings
The purpose of this study would like to learn if acupuncture-like electrical therapy
can be used in patients with head and neck cancer who have had radiation treatment
to treat dry mouth.
View Study Details
DRO72835 / ULUN18075 / Lung 3 vs 5 Fx SBRT / Deepinder Singh
Lead Researcher: Deepinder Singh
This study's goal is to find out if the kind of side effects people experience from
radiation is different depending on the schedule of their radiation treatment. Patients
will be randomly assigned to either the 3 Fraction or 5 Fraction schedule of radiation.
After patients complete radiation treatment, they will follow up with their radiation
oncologist.
View Study Details
Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)
Lead Researcher: R White
Seralutinib is an inhaled medication for PAH. Participants with PAH age 18-75 and
a BMI of 17-40 may be eligible to participate. Participants will be randomized to
either placebo or drug. The duration of the study is up to a maximum of 48 weeks.
View Study Details
EN21-PP/01 Painful Diabetic peripheral Neuropathy Study
Lead Researcher: Mark Williams
The University of Rochester is looking for adults 18 years and older with feet pain
from diabetes to participate in a research study about a new investigational medication.
We want to find out if it can treat foot pain from diabetes. If you are eligible,
you will be asked to: (1) come to 7 visits in our clinic over 7 months, (2) take the
study medication each day, and (3) answer surveys. You will be paid $85 for each completed
visit. Study related examinations and study medication will be provided at no cost.
View Study Details
Fine Eye Movement Study
Lead Researcher: Brian Keane
This study will look at differences in eye movement as they relate to visual perception
and the way people think. The information collected in this study will aid in finding
ways to more accurately diagnose psychiatric disorders, namely schizophrenia, by using
eye scans. Also, results from this study may guide the development of more tailored
therapies to help people with psychiatric disorders in the future. Procedures include:
interviews about your medical and drug use history; a vocabulary test; review of your
eRecord data; visual perceptual tasks completed on a computer; and eye scans (like
those during an eye doctor exam). Some of these procedures may occur via Zoom, depending
on participant preferences. Eligibility: Ages 18-55; a diagnosis of schizophrenia,
schizoaffective disorder, schizophreniform disorder OR no psychiatric disorder with
no more than one lifetime major depressive episode.
View Study Details
Future Contact Database for People with Asthma
Lead Researcher: Steve Georas
The doctors and researchers in the Pulmonary and Critical Care Medicine Division at
the University of Rochester are creating a database (a list) of individuals with asthma
who are interested in taking part in future research studies about asthma. If you
are contacted, you can decide at that time whether or not you are interested in participating
in that study. You may be contacted via telephone, mail, or email. Being included
in the database does not mean that you will be enrolled in that study; rather, you
are only agreeing to be contacted about future research studies. You are eligible
to join if you are 18 years of age or older, have an asthma diagnosis, and are willing
to answer brief questionnaires about your medical history and medication use.
View Study Details
GEMS/Mustian/URCC19178
Lead Researcher: Karen Mustian
This phase III cluster randomized trial compares the effect of geriatric evaluation
and management with survivorship health education (GEMS) to usual care on patient-reported
physical function in older survivors of cancer. Survivorship care for older adults
of cancer usually consists of getting advice from their doctor. This advice may include
how to do their daily activities, so they are less tired or how to manage multiple
diseases, or long-term side effects from treatment. GEMS may help improve the physical
ability to perform activities of daily living, mental well-being, and memory in older
survivors of cancer after chemotherapy. This study may help doctors learn if including
GEMS in their practices improves physical, mental and memory functions in their patients.
The study may also help to understand how such care affects cancer patients and their
caregivers' quality of life.
View Study Details
HEROES Study - Health Effects (Renal) Of Extra Strength Avmacol
Lead Researcher: Thu Le
This study will determine if taking a daily broccoli supplement (Avmacol ES) can decrease
kidney disease progression rate and inflammation in patients with Chronic Kidney Disease
(CKD). The study will enroll 100 patients from the Kidney Clinic in AC3 and Highland
Hospital who have CKD stages 3-4.
View Study Details
Hydrocortisone for premature babies
Lead Researcher: Carl D'angio
The Hydrocortisone and Extubation study will test if giving hydrocortisone for 10
days improves survival for premature infants who have a breathing tube. Infants will
either receive hydrocortisone or placebo.
View Study Details
IBRS19007 / FLEX Registry / Ajay Dhakal
Lead Researcher: Ajay Dhakal
The FLEX Registry will be implemented to operate as a large-scale, population based,
prospective registry. All patients with stage I to III breast cancer who receive MammaPrint®
and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX
Registry, which is intended to enable additional study arms at low incremental effort
and cost. FLEX Registry will utilize an adaptive design, where additional targeted
substudies and arms can be added after the initial study is opened.
View Study Details
ILYM20053 / KT-US-499-0150 / Reagan
Lead Researcher: Patrick Reagan
The goal of this clinical study is to learn more about the safety and dosing of the
study drugs, KITE-363 and KITE-753, in participants with relapsed and/or refractory
B-cell lymphoma.
View Study Details
ILYM21068 / EONHL1-20 / Friedberg
Lead Researcher: Jonathan Friedberg
The purpose of this study is to define the recommended Phase 2 Dose, safety, tolerability,
immunogenicity, and preliminary efficacy of EO2463 during monotherapy and in combination
with lenalidomide and/or rituximab in patients with indolent NHL
View Study Details
IMBRS22048_Dhakal_Celcuity CELC-G-301 Gedatolisib
Lead Researcher: Ajay Dhakal
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy
and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment
of patients with locally advanced or metastatic HR+/HER2- breast cancer following
progression on or after CDK4/6 and aromatase inhibitor therapy.
View Study Details
IMBRS23027_Falkson_J2J-MC-JZLH - EMBER-4
Lead Researcher: Carla Falkson
The main purpose of this study is to measure how well imlunestrant works compared
to standard hormone therapy in participants with early breast cancer that is estrogen
receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants
must have already taken endocrine therapy for two to five years and must have a higher-than-average
risk for their cancer to return. Study participation could last up to 10 years.
View Study Details
IMLT21110 // KT-US-982-5968 // Reagan
Lead Researcher: Patrick Reagan
The goal of this clinical study is to learn more about the long-term safety, effectiveness
and prolonged action of Kite study drugs, axicabtagene ciloleucel, brexucabtagene
autoleucel, KITE-222, KITE-363, KITE-439, KITE-585, and KITE-718, in participants
of Kite-sponsored interventional studies.
View Study Details
IMLYM22090 // M23-647 // Barr
Lead Researcher: Paul Barr
Non-Hodgkin's lymphoma (NHL) is a cancer that arises from the transformation of normal
B and T lymphocytes (white blood cells). The purpose of this study is to assess the
safety, pharmacokinetics, and preliminary efficacy of ABBV-101 in adult participants
in relapsed or refractory (R/R) non-Hodgkin's lymphomas: third line or later of treatment
(3L) + chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), diffuse
large b-cell lymphoma (DLBCL), non-germinal center B cell (GCB) DLBCL, mantle cell
lymphoma (MCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), Waldenström
macroglobulinemia (WM), or transformed indolent NHL. Adverse events will be assessed.
ABBV-101 is an investigational drug being developed for the treatment of NHL. This
study will include a dose escalation phase to determine the maximum administered dose
(MAD)/Maximum tolerated dose (MTD) of ABBV-101 and a dose expansion phase to determine
the change in disease activity in participants with CLL or non-GCB DLBCL. Approximately
128 adult participants with multiple NHL subtypes will be enrolled in the study in
sites world wide.
In the Dose Escalation phase of the study participants will receive escalating oral
doses of ABBV-101, until the MAD/MTD is determined, as part of the approximately 60
month study duration. In the dose expansion phase of the study participants receive
oral ABBV-101, as part of the approximately 60 month study duration .
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at an approved
institution (hospital or clinic). The effect of the treatment will be frequently checked
by medical assessments, blood tests, and side effects.
View Study Details
IMMEL22088_Sahasrabudhe_R3767-ONC-2055
Lead Researcher: Deepak Sahasrabudhe
This study is researching an experimental drug called REGN3767, also known as fianlimab
(R3767), when combined with another medication called cemiplimab (each individually
called a "study drug" or called "study drugs" when combined) compared with an approved
medication called pembrolizumab.
The objective of this study is to see if the combination of fianlimab and cemiplimab
is an effective treatment compared to pembrolizumab in patients that have had melanoma
removal surgery but are still at high risk for the recurrence of the disease. Pembrolizumab
is an approved treatment in some countries in this clinical setting.
The study is looking at several other research questions, including:
* What side effects may happen from receiving the study drugs.
* How much study drug is in the blood at different times.
* Whether the body makes antibodies against the study drug (which could make the drug
less effective or could lead to side effects). Antibodies are proteins that are naturally
found in the blood stream that fight infections.
* How administering the study drugs might improve quality of life.
View Study Details
IMMLT23021 // ACR-368-201 (GOG 3082) // Guercio
Lead Researcher: Brendan Guercio
This is an open label Phase 1b/2 study to evaluate the efficacy and safety of ACR-368
as monotherapy or in combination with ultralow dose gemcitabine in participants with
platinum-resistant ovarian carcinoma, endometrial adenocarcinoma, and urothelial carcinoma
based on Acrivon's OncoSignature® test status.
View Study Details
IMMY20144/ 64407564MMY1001/ Brea Lipe
Lead Researcher: Brea Lipe
The purpose of this study is to evaluate the efficacy and safety of talquetamab in
participants with relapsed or refractory multiple myeloma at the recommended Phase
2 dose(s) (RP2Ds) (Part 3).
View Study Details
Intellectual & Developmental Disabilities Research Center Contact Registry
Lead Researcher: Alexander Paciorkowski
The University of Rochester's Intellectual & Developmental Disabilities Research Center
(IDDRC) is creating a research study contact database for those with intellectual
and developmental disabilities (IDDs). This will help keep people with IDDs, and their
families, informed about opportunities to join research studies that can impact the
way healthcare is provided, improving the health and wellbeing of those with IDDs.
When you join this contact database, you may be contacted about future research study
opportunities at the University of Rochester. There are a variety of studies that
may be offered, and some studies may offer compensation. There is no obligation to
participate in any of the future studies for which you are contacted. You can always
withdraw from a research study at any time without penalty. If you have an IDD diagnosis,
you can sign up to be a part of this database (it’s okay for a legal guardian to help
with the sign-up if needed). Qualifying diagnoses include, but are not limited to,
autism spectrum disorders, developmental delay, intellectual disability, Down syndrome,
fetal alcohol spectrum disorder, cerebral palsy, MECP2 mutation (e.g., Rett Syndrome),
Batten disease and Angelman syndrome, as well as epilepsy/seizure conditions, tuberous
sclerosis and movement disorders with a corresponding IDD.
View Study Details
Interactive Group Drumming and "Chemo Brain"
Lead Researcher: Gaelen Mccormick
If you decide to take part in this study, you will be asked to participate, as you
are able,
in four consecutive weekly drumming groups of up to ten people occurring at the same
time each week, led by a professional facilitator. Each group will be one hour in
length. During these groups, the facilitator will invite subjects to follow simple
oral (singing and speaking) and musical instructions by playing the drums we will
provide.
At the beginning and the end of each session, you will be asked to answer a brief
questionnaire about your state of wellbeing. At the beginning and end of the study,
you will be asked to answer a survey about cognitive function (and your experience
with “chemo brain”) using the FACT COG assessment survey. After the study concludes,
you will be asked to answer a survey about satisfaction with your experience of the
drumming session. Your participation will last about 4 weeks.
View Study Details
IPNEU22061 / DAY101-002 / Korones
Lead Researcher: David Korones
This is a 2-arm, randomized, open-label, multicenter, global, Phase 3 trial to evaluate
the efficacy, safety, and tolerability of tovorafenib monotherapy versus standard
of care (SoC) chemotherapy in patients with pediatric low-grade glioma (LGG) harboring
an activating rapidly accelerated fibrosarcoma (RAF) alteration requiring front-line
systemic therapy.
View Study Details
IPNEU23016 // ONC201-108 // Korones
Lead Researcher: David Korones
This is a randomized, double-blind, placebo-controlled, parallel-group, international,
Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess
whether treatment with ONC201 following frontline radiotherapy will extend overall
survival and progression-free survival in this population. Eligible participants will
have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard
frontline radiotherapy.
View Study Details
ISCR2201MN (Nucleix)
Lead Researcher: Michael Nead
This study is part of the development and validation of a non-invasive lung screening
test which aim to identify early stage lung cancer in patients at high risk for lung
cancer.
View Study Details
Longitudinal Subtyping Of Atopic Dermatitis Through Skin Analysis
Lead Researcher: Lisa Beck
This is a study which will characterize the gene expression
profiles that underlie mild and moderate-severe Atopic
dermatitis (AD). It will determine changes in these expression patterns in
response to standard-of-care treatment. Participants will complete up to ten study
visits
with assessment of topical steroid response and dupilumab response (if uncontrolled
with
topical steroids). Skin samples will be collected at all study visits to determine
the gene
expression profiles that underlie mild vs. moderate-severe atopic dermatitis.
Healthy participants without atopic dermatitis will serve as a control population
and must agree to apply a topical moisturizer (Vanicream) at least twice daily for
7 days.
Atopic dermatitis patients must have chronic AD with active lesions.
View Study Details
Lymphoma & Leukemia: Collection of specimens and epidemiological and clinical outcomes
data in patients with hematological malignancies
Lead Researcher: Walter Burack
This research is being done because we hope that a better understanding of hematologic
malignancies will allow us to develop new and better treatments.
View Study Details
Measuring Surgical Recovery After Radical Cystectomy
The intent of this study is to establish a registry of post‐surgical outcomes in patients
undergoing radical cystectomy. The goals of this initiative are to obtain a detailed
baseline of multiple
patient‐reported outcomes (PRO) and clinician‐reported outcomes (CRO) as well as various
presenting conditions associated with them, so that future quality improvement interventions
can be evaluated accurately as to their relative contribution to improved outcomes.
View Study Details
Music training for concerts for people with hearing aids or cochlear implants
Lead Researcher: Gaelen Mccormick
This is a study of a novel music-listening training intervention. Half the subjects
will be randomly assigned to the music listening training modules intervention and
the remaining subjects will be assigned to the waitlist control (offered the intervention
upon study completion). All subjects will: (1) attend two 45- to 60-minute concerts
held at the Eastman School of Music, approximately 10 to 12 weeks apart; (2) complete
2 questionnaires directly following the concerts about their music listening habits,
preferred music genres, and issues associated with attending concerts. Between the
two concerts, individuals in the intervention arm will be provided 15-minute training
sessions as podcasts that subjects can listen to twice a week for 8 weeks (16 podcasts)
at times and places of their choosing.
View Study Details
NRG-BN012 / CRNEU23065 / Milano
Lead Researcher: Michael Milano
This phase III trial compares the addition of stereotactic radiosurgery before or
after surgery in treating patients with cancer that has spread to the brain (brain
metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers
a high dose of radiation only to the small areas of cancer in the brain and avoids
the surrounding normal brain tissue. Surgery and radiation may stop the tumor from
growing for a few months or longer and may reduce symptoms of brain metastases.
View Study Details
NRG-BR008 HERO / CRBRS23022 / Gergelis
Lead Researcher: Kimberly Gergelis
This Phase III trial compares the recurrence-free interval (RFI) among patients with
early-stage, low risk HER2+ breast cancer who undergo breast conserving surgery and
receive HER2-directed therapy, and are randomized to not receive adjuvant breast radiotherapy
versus those who are randomized to receive adjuvant radiotherapy per the standard
of care.
View Study Details
NRG-GU008 / RGUP20037 / INNOVATE / Hong Zhang
Lead Researcher: Hong Zhang
This phase III trial studies whether adding apalutamide to the usual treatment improves
outcome in patients with lymph node positive prostate cancer after surgery. Radiation
therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or
male sex hormones, can cause the growth of prostate cancer cells. Drugs, such as apalutamide,
may help stop or reduce the growth of prostate cancer cell growth by blocking the
attachment of androgen to its receptors on cancer cells, a mechanism similar to stopping
the entrance of a key into its lock. Adding apalutamide to the usual hormone therapy
and radiation therapy after surgery may stabilize prostate cancer and prevent it from
spreading and extend time without disease spreading compared to the usual approach.
View Study Details
NRG-GU009 / RGUP21002 / PREDICT-RT / Kevin Bylund
Lead Researcher: Kevin Bylund
This phase III trial compares less intense hormone therapy and radiation therapy to
usual hormone therapy and radiation therapy in treating patients with high risk prostate
cancer and low gene risk score. This trial also compares more intense hormone therapy
and radiation therapy to usual hormone therapy and radiation therapy in patients with
high risk prostate cancer and high gene risk score. Apalutamide may help fight prostate
cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses
high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy
treatment may work the same at controlling prostate cancer compared to the usual 24
month hormone therapy treatment in patients with low gene risk score. Adding apalutamide
to the usual treatment may increase the length of time without prostate cancer spreading
as compared to the usual treatment in patients with high gene risk score.
View Study Details
NRG-GU010 / RGUP21107 / GUIDANCE / Michael Cummings
Lead Researcher: Michael Cummings
This phase III trial uses the Decipher risk score to guide intensification (for higher
Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment
to better match therapies to an individual patient's cancer aggressiveness. The Decipher
risk score evaluates a prostate cancer tumor for its potential for spreading. In patients
with low risk scores, this trial compares radiation therapy alone to the usual treatment
of radiation therapy and hormone therapy (androgen deprivation therapy). Radiation
therapy uses high energy x-rays or particles to kill tumor cells and shrink tumors.
Androgen deprivation therapy blocks the production or interferes with the action of
male sex hormones such as testosterone, which plays a role in prostate cancer development.
Giving radiation treatment alone may be the same as the usual approach in controlling
the cancer and preventing it from spreading, while avoiding the side effects associated
with hormonal therapy. In patients with higher Decipher gene risk, this trial compares
the addition of darolutamide to usual treatment radiation therapy and hormone therapy,
to usual treatment. Darolutamide blocks the actions of the androgens (e.g. testosterone)
in the tumor cells and in the body. The addition of darolutamide to the usual treatment
may better control the cancer and prevent it from spreading.
View Study Details
NRG-LU008 / CRLUN23043 / NRG / SINGH
Lead Researcher: Deepinder Singh
This phase III trial compares the effect of adding stereotactic body radiation therapy
(SBRT) to standard treatment (image guided radiation therapy \[IGRT\] and chemotherapy
followed by immunotherapy with durvalumab) versus standard treatment alone in treating
patients with non-small cell lung cancer that cannot be treated by surgery (inoperable).
SBRT uses special equipment to position a patient and deliver radiation to tumors
with high precision. This method may kill tumor cells with fewer doses over a shorter
period and cause less damage to normal tissue. IGRT is a type of radiation that uses
a computer to create picture of the tumor, to help guide the radiation beam during
therapy, making it more accurate and causing less damage to healthy tissue. Standard
chemotherapy used in this trial consists of combinations of the following drugs: cisplatin,
carboplatin, paclitaxel, pemetrexed, and etoposide. Cisplatin is in a class of medications
known as platinum-containing compounds. It works by killing, stopping or slowing the
growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing
compounds. It works in a way similar to the anticancer drug cisplatin, but may be
better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing
the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule
agents. It works by stopping the growth and spread of tumor cells. Pemetrexed is in
a class of medications called antifolate antineoplastic agents. It works by blocking
the action of a certain substance in the body that may help tumor cells multiply.
Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks
a certain enzyme needed for cell division and DNA repair and may kill tumor cells.
Immunotherapy with durvalumab, may induce changes in body's immune system and may
interfere with the ability of tumor cells to grow and spread. Adding SBRT to the standard
treatment of IGRT with chemotherapy and immunotherapy may be more effective at treating
patients with inoperable non-small cell lung cancer than giving the standard treatment
alone.
View Study Details
Observational Study of ICU Patients with Systemic Inflammatory Response Syndrome (SIRS)
Lead Researcher: Anthony Pietropaoli
This is an observational research study of subjects admitted to the ICU with severe
SIRS (and/or sepsis).
For ICU subjects enrolled: the study involves collecting up to 2 blood samples (3-5
days apart), data collection, and post-discharge follow-up questionnaires.
For healthy volunteers: Subjects age 65 and older are needed for a one-time blood
sample collection for comparison studies. A brief health questionnaire and set of
vital signs will also be collected at the study visit.
Volunteers must be age 65 or older and cannot be on antibiotics or antivirals for
current infection. Volunteers also must not have had an infection within 6 weeks prior
to the study visit.
View Study Details
Outcome Disparities in Adolescents with Acute Lymphoclastic Leukemia (ALL)
Lead Researcher: Kristen O'Dwyer
We will establish two prospective groups of patients with Acute Lymphoclastic Leukemia
(ALL):
"Cohort A" will be enrolled on the study at the time of diagnosis while "Cohort B"
will be enrolled during maintenance chemotherapy.
View Study Details
Parent Cafe Study for Caregivers of Children with Medical Complexity
Lead Researcher: Nathaniel Bayer
We started monthly peer and emotional support group sessions for caregivers of children
with medical complexity. We are looking for interested parents and caregivers to participate
in our research, attend support sessions, and provide feedback to improve them. A
child with medical complexity means that a child has/had 2 or more long-term diagnoses
and uses/used medical devices (like a feeding tube or tracheostomy).
Depending on the status and age of your child, you could either help us design the
support groups, lead the support groups, or participate in the support groups as an
attendee. Families with different diagnoses, outcomes, racial and ethnic backgrounds,
genders, sexual orientations, religions, geographic regions and physical abilities
all provide important insight and perspective. We are recruiting caregivers of children
who have fully recovered, have recovered with ongoing needs, are undergoing treatment,
or have passed away. Your lived experience and perspective matters.
View Study Details
PASSAGE: Effectiveness of Tezepelumab, an Injectable Medication, in Treating Severe
Asthma
Lead Researcher: Steve Georas
Adult and adolescent participants may be eligible if they have severe asthma with
2 or more exacerbations in the last 12 months. The study consists of 15 in-person
visits (1 to 3 hours each). Visit 1 will be for eligibility screening. The study drug,
tezepelumab, will be given at visits 2-14. Visit 15 will be for follow-up examination.
View Study Details
PBRT20077 / ACNS1831 / Korones
Lead Researcher: David Korones
This phase III trial studies if selumetinib works just as well as the standard treatment
with carboplatin/vincristine (CV) for subjects with NF1-associated low grade glioma
(LGG), and to see if selumetinib is better than CV in improving vision in subjects
with LGG of the optic pathway (vision nerves). Selumetinib is a drug that works by
blocking some enzymes that low-grade glioma tumor cells need for their growth. This
results in killing tumor cells. Drugs used as chemotherapy, such as carboplatin and
vincristine, work in different ways to stop the growth of tumor cells, either by killing
the cells, by stopping them from dividing, or by stopping them from spreading. It
is not yet known whether selumetinib works better in treating patients with NF1-associated
low-grade glioma compared to standard therapy with carboplatin and vincristine.
View Study Details
PCCO15102 / APEC14B1 / EveryChild Protocol / Kazi
Lead Researcher: Rafi Kazi
This study gathers health information for the Project: Every Child for younger patients
with cancer. Gathering health information over time from younger patients with cancer
may help doctors find better methods of treatment and on-going care.
View Study Details
PGUK06001 / AREN03B2 / Kazi
Lead Researcher: Rafi Kazi
This research trial studies kidney tumors in younger patients. Collecting and storing
samples of tumor tissue, blood, and urine from patients with cancer to study in the
laboratory may help doctors learn more about changes that occur in deoxyribonucleic
acid (DNA) and identify biomarkers related to cancer.
View Study Details
PHEM15022 / PIDTC-6901 / Jeffrey Andolina
Lead Researcher: Jeffrey Andolina
This study is a prospective evaluation of children with Severe Combined Immune Deficiency
(SCID) who are treated under a variety of protocols used by participating institutions.
In order to determine the patient, recipient and transplant-related variables that
are most important in determining outcome, study investigators will uniformly collect
pre-, post- and peri-transplant (or other treatment) information on all children enrolled
into this study.
Children will be divided into three strata:
* Stratum A: Typical SCID with virtual absence of autologous T cells and poor T cell
function
* Stratum B: Atypical SCID (leaky SCID, Omenn syndrome and reticular dysgenesis with
limited T cell diversity or number and reduced function), and
* Stratum C: ADA deficient SCID and XSCID patients receiving alternative therapy including
PEG-ADA ERT or gene therapy.
Each Group/Cohort Stratum will be analyzed separately.
View Study Details
PHEM15023 / PIDTC-6903 / Jeffrey Andolina
Lead Researcher: Jeffrey Andolina
Chronic granulomatous disease (CGD) is an inherited immune system abnormality in which
bone marrow transplantation (BMT) has been shown to be curative. However the risks
of transplantation are high and not all patients with CGD may need to undergo this
high risk procedure. This study will determine the long term medical condition and
daily functioning of participants with CGD after a transplant and if possible, compare
these results to participants who do not undergo a transplant.
View Study Details
PLEU19175 / AALL1732 / Kazi
Lead Researcher: Rafi Kazi
This phase III trial studies whether inotuzumab ozogamicin added to post-induction
chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL)
improves outcomes. This trial also studies the outcomes of patients with mixed phenotype
acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL
therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody,
called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab
attaches to cancer cells in a targeted way and delivers calicheamicin to kill them.
Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine,
dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine,
prednisone, thioguanine, vincristine, and pegaspargase or calaspargase pegol work
in different ways to stop the growth of cancer cells, either by killing the cells,
by stopping them from dividing, or by stopping them from spreading. This trial will
also study the outcomes of patients with mixed phenotype acute leukemia (MPAL) and
disseminated B lymphoblastic lymphoma (B-LLy) when treated with high-risk ALL chemotherapy.
The overall goal of this study is to understand if adding inotuzumab ozogamicin to
standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute
Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first
two phases of therapy: Induction and Consolidation. This part will collect information
on the leukemia, as well as the effects of the initial treatment, to classify patients
into post-consolidation treatment groups. On the second part of this study, patients
with HR B-ALL will receive the remainder of the chemotherapy cycles (interim maintenance
I, delayed intensification, interim maintenance II, maintenance), with some patients
randomized to receive inotuzumab. The patients that receive inotuzumab will not receive
part of delayed intensification. Other aims of this study include investigating whether
treating both males and females with the same duration of chemotherapy maintains outcomes
for males who have previously been treated for an additional year compared to girls,
as well as to evaluate the best ways to help patients adhere to oral chemotherapy
regimens. Finally, this study will be the first to track the outcomes of subjects
with disseminated B-cell Lymphoblastic Leukemia (B-LLy) or Mixed Phenotype Acute Leukemia
(MPAL) when treated with B-ALL chemotherapy.
View Study Details
PLEU21111 / APAL2020SC / Kazi
Lead Researcher: Rafi Kazi
This study aims to use clinical and biological characteristics of acute leukemias
to screen for patient eligibility for available pediatric leukemia sub-trials. Testing
bone marrow and blood from patients with leukemia that has come back after treatment
or is difficult to treat may provide information about the patient's leukemia that
is important when deciding how to best treat it, and may help doctors find better
ways to diagnose and treat leukemia in children, adolescents, and young adults.
View Study Details
PMLT12010 / ALTE05N1 / Kazi
Lead Researcher: Rafi Kazi
This clinical trial keeps track of and collects follow-up information from patients
who are currently enrolled on or have participated in a Children's Oncology Group
study. Developing a way to keep track of patients who have participated in Children's
Oncology Group studies may allow doctors learn more about the long-term effects of
cancer treatment and help them reduce problems related to treatment and improve patient
quality of life.
View Study Details
Povidone Iodine Study for Childhood Cavities
Lead Researcher: Dorota Kopycka-kedzierawski
This is a clinical trial to determine whether 10% Povidone Iodine prevents
new cavities when applied to the teeth of children with Severe Early
Childhood Caries (S-ECC). Study participants will be followed for approximately 24
months after receiving treatment.
Children age 24 to 71 months with parents/guardians who are 18 or older are eligible.
Children must be diagnosed with Severe-Early Childhood Caries (S-ECC) requiring treatment
in the
operating room.
View Study Details
PRG Contact Database
Lead Researcher: Brian Keane
This future contact database will facilitate contact with prospective subjects, giving
them greater opportunities to participate in behavioral and neuroimaging studies for
which they may be eligible.
View Study Details
Psychosis-Risk Outcomes Study (ProNET)
Lead Researcher: Steven Silverstein
The purpose of this research study is to collect information from individuals who
are considered at clinically high risk for the possible development of psychosis.
Information will also be collected from healthy individuals who are not considered
at high risk for psychosis. This information will be used to guide future treatments.
Participants will participate in interviews and cognitive tasks, provide blood samples,
saliva and DNA, and get a scan of their brain. You may participate up to 2 years.
You must be between 12 and 30 years old. There are other requirements to join the
study. The study team can review them with you.
View Study Details
RESET-SLE: Study to Evaluate the Safety and Efficacy of CABA-201 in People With Active
Systemic Lupus Erythematosus
Lead Researcher: Christopher Palma
Systemic lupus erythematosus (SLE) is a disease where the immune system attacks healthy
tissue.
SLE can be unpredictable, flaring up and calming down over time. In some cases, it
can damage organs like the kidneys, leading to a serious complication called lupus
nephritis (LN). This can hurt your health and even be life-threatening.
Unfortunately, there isn't a cure for lupus yet. Medications we have now can help
manage the disease, but they often have side effects and sometimes aren't strong enough
for severe cases.
This is why scientists are actively researching new treatments for lupus, especially
effective ones with fewer side effects, to help people with this challenging condition.
This study will determine if a new drug, called CABA-201, will help SLE patient with
lupus nephritis.
You may be eligible to participate if you are 18-65 years old and have a clinical
diagnosis of SLE.
View Study Details
Safety, Tolerability, PK, and PD Study of PGN-EDODM1 in Participants With Myotonic
Dystrophy Type 1
Lead Researcher: Johanna Hamel
The purpose of this study is to learn about the effects of an “investigational” drug,
PGN-EDODM1, and to see how safe and tolerable PGN-EDODM1 is for people with myotonic
dystrophy type 1 compared to placebo. The study consists of 2 periods: A Screening
Period (up to 30 days) and a Treatment and
Observation Period (16 weeks). You will come to the site for 6 visits over the course
of the study. Compensation is provided for participating. You are eligible if you
have a diagnosis of myotonic dystrophy type 1 and myotonia (muscles that do not relax
after contraction).
View Study Details
SGIP21027 / Semaphorin 4D / Mulkerin
Lead Researcher: Daniel Mulkerin
This trial will assess the safety and tolerability of Pepinemab in combination with
Avelumab in patients with metastatic pancreatic adenocarcinoma that has progressed
after first line chemotherapy. Phase 2 will assess the efficacy of this combination
therapy.
View Study Details
Social Engagement Coaching for Caregivers
Lead Researcher: Kathi Heffner
Taking care of someone who has dementia can become increasingly difficult. The well-being
of the caregiver is important for both themselves and the person they care for. Healthy
social connections are a vital part of this.
The purpose of this study is to evaluate the effects of the Social Engage coaching
program on caregivers’ well-being.
This evidence-based, individualized program focuses on goals that are important to
you and addresses the social barriers often encountered while caring for a loved one
with dementia.
The Social Engage program involves up to nine 30-minute virtual sessions (via Zoom
or phone) conducted over 8-10 weeks, with flexible scheduling. Sessions are one-on-one,
private meetings with a trained coach, and focused on your unique situation and the
social connections that are important to you.
Participation also involves 2 in-person study visits, one before and one after completing
the Social Engage program. Visits are flexibly scheduled and parking is free.
Study visits involve answering questions about yourself, including your mood and feelings
of stress, and what caregiving has been like for you. We will also gather information
about your physical and brain health.
View Study Details
Specialized Phototherapy in Parkinson's Disease
Lead Researcher: Jamie Adams
This is a pivotal study to determine whether light therapy can improve non-motor and
motor
function in Parkinson's disease, on top of current best medical treatment. You may
be eligible for this study if you have a diagnosis of Parkinson's disease.
View Study Details
Spoken Language Comprehension in Adolescents
Lead Researcher: Loisa Bennetto
In this online study, an adolescent will schedule a Zoom appointment with a researcher
and complete a computer-based listening study that may take up to 45 minutes. The
parent will then complete background information surveys, which may take up to 20
minutes. Participants will be compensated via an electronic gift card. We hope that
this research will lead to a better understanding of everyday spoken language communication
and social interactions in adolescents with and without autism.
We are currently recruiting adolescents aged 13-17 without autism.
Please make sure to add an email address so that we can contact you!
View Study Details
Study of T900607-Sodium in Chemotherapy Naive Patients With Hepatocellular Carcinoma.
The purpose of the study is to determine whether T900607-sodium is effective and safe
in
treating hepatocellular carcinoma, a type of liver cancer.
View Study Details
Study on Oral Medication, Selgantolimod, for Treating Hepatitis B in Participants
With Both HIV and Chronic Hepatitis B
Lead Researcher: Sonal Munsiff
This study will asses the safety of an oral medication, called Selgantolimod, which
may help reduce the amount of hepatitis B virus in the blood. In this study, Selgantolimod
will be given over a 6-month period to participants that are dually infected with
HIV and chronic hepatitis B. Participants will need to have been taking suppressive
antiviral therapy for both viruses - for at least the last 5 years - to be eligible.
View Study Details
STUDY00006829: Cedars-Sinai - Microscopic Hematuria_UGUB21108
Lead Researcher: Edward Messing
To improve upon the non-invasive detection of BCa by further validating a multiplex
ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples
of patients with microscopic hematuria.
View Study Details
SWAT BE
Lead Researcher: Vivek Kaul
The purpose of this research study is to learn about the best approach to sample patients
with known or suspected Barrett's esophagus (BE) by comparing the standard Seattle
biopsy protocol to sampling using wide area transepithelial sampling (WATS3D).
Barrett's esophagus is a common condition that is used to spot patients at increased
risk of developing a type of cancer in the esophagus (swallowing tube) called esophageal
adenocarcinoma. The 5-year survival rate is as low as 18% for patients who get esophageal
adenocarcinoma, but the rate may be improved if the cancer is caught in its early
stages. Barrett's esophagus can lead to dysplasia, or precancerous changes, which
occurs when cells look abnormal but have not developed into cancer. If the abnormal
cells increase from being slightly abnormal (low-grade dysplasia), to being very abnormal
(high-grade dysplasia), the risk of developing cancer (esophageal adenocarcinoma)
goes up. Therefore, catching dysplasia early is very important to prevent cancer.
Endoscopic surveillance is a type of procedure where endoscopists run a tube with
a light and a camera on the end of it down a patients throat and remove a small piece
of tissue. The piece of tissue, called a biopsy, is about the size of the tip of a
ball-point pen and is checked for abnormal cells and cancer cells.
Patients are being asked to be in this research study because they have been diagnosed
with BE or suspected to have BE, and will need an esophagogastroduodenoscopy (EGD).
Patients with BE undergo sampling using the Seattle biopsy protocol during which samples
are obtained from the BE in a four quadrant fashion every 2 cm along with target biopsies
from any abnormal areas within the BE. Another sampling approach is WATS3D which utilizes
brushings from the BE.
While both of these procedures are widely accepted approaches to sampling patients
with BE during endoscopy, there is not enough research to show if one is better than
the other.
Participants in this study will undergo sampling of the BE using both approaches (Seattle
biopsy protocol and WATS-3D); the order of the techniques will be randomized.
Up to 2700 participants will take part in this research. This is a multicenter study
involving several academic, community and private hospitals around the country.
View Study Details
The REBALANCE Study - a Study of the May Health System in women with infertility
Lead Researcher: Wendy Vitek
The purpose of this research is to investigate the safety and effectiveness of an
investigational medical device for the treatment of infertility in women with polycystic
ovary syndrome (PCOS). You may be eligible for this study if you are 18 - 40 years
old and are infertile with evidence of PCOS. Other criteria may apply.
View Study Details
The REPLACE Registry-for people who take Cholbam/Kolbam (Cholic Acid)
Lead Researcher: Nanda Kerkar
This is a study for people who take Cholbam/Kolbam also known as Cholic acid. You
will be in this study for 10 years and we will collect information about your health.
View Study Details
To Find the Best Dose of pVGI.1(VEGF2) to Benefit Angina Patients When Given With
an Experimental Injection Catheter
The purpose of this study is to determine the optimum effective dose of recombinant
plasmid
DNA [pVGI.1(VEGF2)] gene therapy administered using an experimental cardiac direct
injection
catheter (Stiletto™) system needed to benefit patients with severe Angina Pectoris.
View Study Details
Total-Body Irradiation, Fludarabine, and Peripheral Stem Cell Transplantation in Treating
Patients With Hematologic Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs
used in
chemotherapy use different ways to stop cancer cells from dividing so they stop growing
or
die. Combining chemotherapy with donor peripheral stem cell transplantation may allow
the
doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining total-body irradiation
with
fludarabine and donor peripheral stem cell transplantation in treating patients who
have
hematologic cancer.
View Study Details
UBMT15029 / Cord Blood IIT / Omar Aljitawi
Lead Researcher: Omar Aljitawi
This study is a single-center, treatment protocol with 4 possible preparative regimens,
designed to validate the process of umbilical cord blood stem cell transplantation
at our institution.
View Study Details
UBMT17044 / HBO-UBC / Omar Aljitawi
Lead Researcher: Omar Aljitawi
The UCB transplant is a type of stem cell transplant used to treat cancer of the blood
or lymph glands. The UCB transplant has advantages over other types of transplants
such as ease of obtaining the umbilical cord blood, absence of donor risks, reduced
risks of contagious infections, and the availability for immediate use. The UCB transplant
is also associated with a lower incidence of graft versus host disease, or GvHD (in
GvHD, the transplanted graft attacks the recipient organs).
View Study Details
UBRS20139 / FACT-5 / Ajay Dhakal
Lead Researcher: Ajay Dhakal
The purpose of this research is to look at the safety and effectiveness of a HER2-targeted
therapy neratinib when given with capecitabine, a chemotherapy, for breast cancer
patients with brain metastases whose tumors were HER2-negative by standard tests but
showed abnormal HER2 activity based on the CELsignia results.
View Study Details
UBRS20152 / BTCRC BRE15-024 / O'Regan
Lead Researcher: Ruth O'Regan
This is an open label, multi-institutional, single arm phase II trial of ribociclib
in combination with bicalutamide in advanced AR+ triple-negative breast cancer. No
randomization or blinding is involved.
View Study Details
UBRS21032 / HCRN-BRE17-141 / O'Regan
Lead Researcher: Ruth O'Regan
Patient will be treated with neratinib, an aromatase inhibitor and trastuzumab for
24 weeks prior to surgery, following an initial 3 weeks of neratinib alone, aromatase
inhibitor alone or the combination of neratinib and an aromatase inhibitor. A breast
biopsy will be performed prior to Day 1 of week 4 of treatment. Following surgery,
patients will receive standard of care HER2-directed and endocrine therapy at the
treating physician's discretion.
View Study Details
UBRT21040 / Early START / Nimish Mohile (formerly Sara Hardy)
Lead Researcher: Nimish Mohile
High grade gliomas (HGGs) are rapidly progressive brain tumors resulting in death
for most patients between 6 months and 2 years after diagnosis. It is important for
patients with HGG to discuss and document their wishes at the end of life. However,
many of these patients experience early changes in cognition which impede their decision-making.
For this reason, these patients should have early discussions with their providers.
However, implementation of this remains challenging in clinical practice.
In this study, we will create an Early STructured Advanced care Referrals by Telehealth
(Early START) visit for patients soon after their initial oncology visit. A checklist
and pre-visit guide were developed to help guide the visit for both the provider and
patient. Providers will receive special training in running these visits. Caregivers
and/or family members will be encouraged to participate. Visits will be done using
video or telephone and recorded. For patients who do not have access to technology
for these visits, it will be provided. After the visit, patients, caregivers and/or
family who participated, and providers will fill out surveys to address feasibility
of having these extra visits and improve the visits for future. Patients will be followed
until death. Caregivers and/or family who participated will be asked about whether
end of life was in line with the patient's wishes. We will also use the patient's
medical record to assess other aspects of end of life. We will compare end of life
outcomes with other similar patients treated at our center.
View Study Details
UCCS19102 / MAAT-G JIT (Breast) / Magnuson
Lead Researcher: Allison Magnuson
Cancer-related cognitive dysfunction (CRCD) affects up to 75% of patients receiving
chemotherapy and older adults are at greater risk of developing CRCD, which can negatively
affect their functional independence and quality of life. Memory and Attention Adaptation
Training (MAAT) is a promising treatment for CRCD that improves perceived cognition
in younger cancer survivors, but needs to be adapted for older adults to address their
unique needs. The proposed study will adapt MAAT for older adults using feedback from
key stakeholders (older adults with cancer and their caregivers), and subsequently
test the ability of MAAT to improve or maintain cognition for older adults with breast
cancer receiving adjuvant chemotherapy.
View Study Details
UCCS21043 / Go-EXCAP II / Loh
Lead Researcher: Kah Poh Loh
This is a phase 2 randomized controlled trial (RCT) to assess the preliminary efficacy
of the a mobile health exercise intervention (GO-EXCAP) versus a chemotherapy education
control in 100 older patients with MN receiving outpatient chemotherapy on physical
function and patient-reported outcomes (fatigue, mood, and quality of life). We will
also explore the effect of the intervention on TNFα and related cytokine gene promoter
methylation and their gene and protein expression.
View Study Details
UGIP20027, Dunne, CA209-7WU, Pancreatic Ductal Adenocarcinoma, SX-682, Nivolumab
Lead Researcher: Richard Dunne
The main purpose of this research study is to determine the maximum tolerable dose
(MTD) of SX-682 in combination with nivolumab in patients with metastatic pancreatic
ductal adenocarcinoma who have completed at least 16 weeks of first line chemotherapy
treatment without evidence of disease progression.
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UGUK17036 / Fung RCC Carevive Pilot IIT / Chunkit Fung
Lead Researcher: Chunkit Fung
To determine if Carevive software, which monitors treatment-related toxicities and
then generates self-care management plans for these symptoms, will be feasible to
implement among patients with metastatic renal cell carcinoma (RCC). Additionally
for collection of preliminary data on treatment-related toxicities, quality of life,
distress level, and drug adherence.
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UGUP18071 / DORA / Chunkit Fung
Lead Researcher: Chunkit Fung
The purpose of this study is to compare any good and bad effects of using radium-223
along with docetaxel chemotherapy treatment versus using docetaxel alone. Earlier
studies helped show that the combination is safe, but the combination has not been
proven to work better than either drug alone. The goal of this study is to find out
if combining docetaxel and radium-223 is better than giving either drug by itself.
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UGYO17017 / MD Anderson / Richard Moore
Lead Researcher: Richard Moore
The goal of this clinical research study is to evaluate a method involving 4 blood
tests called CA-125, HE4, HE4 antigen autoantibody complexes, and osteopontin that
may be helpful in the early detection of ovarian cancer in women who are at low risk.
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ULAB03012 / LEO / Richard Burack
Lead Researcher: Walter Burack
The goal of this infrastructure grant is to establish and maintain a cohort of over
12,000 non-Hodgkin lymphoma (NHL) patients to support broad and cutting-edge research
that identifies clinical (including co-morbid diseases), epidemiologic (including
lifestyle and other exposures), host genetic, tumor, and treatment factors, as well
as the interaction among these factors, on short and long-term outcomes. These efforts
will identify new approaches to improve the survival and well-being of NHL patients.
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ULAB21028 / LEO / Friedberg
Lead Researcher: Jonathan Friedberg
The goal of this infrastructure protocol is to build and maintain a large and diverse
observational cohort study to support broad and cutting-edge research focused on NHL
prognosis and survivorship. The LEO cohort will promote identification of clinical
(including co-morbid diseases), epidemiologic (including lifestyle and other exposures),
host genetic, tumor, and treatment factors that impact multiple outcomes (including
event-free, overall and lymphoma-specific survival; new onset comorbidities; and patient-reported
outcomes). This resource also will allow examination of the interaction among these
factors in order to better understand the clinical and molecular epidemiology of outcomes
in NHL. Ultimately, this approach will drive discovery and validation of treatment
endpoints, improve prognostication, and identify novel approaches to improve short
and long-term outcomes for NHL patients.
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ULEU07047 / RSRB20123 / Michael Becker
Lead Researcher: Jane Liesveld
This study is being performed to develop assays to determine the impact of the therapy
patients receive for treatment of AML or MDS and to determine if these tests can identify
those patients who are at a greater risk for having their disease relapse.
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ULYM18040 / DLBCL / Carla Casulo
Lead Researcher: Carla Casulo
The overarching goals of this study are to measure levels of circulating tumor DNA
(ctDNA) in patients with early stage diffuse large B cell lymphoma (DLBCL), to assess
the change in ctDNA during treatment in order to prospectively identify markers of
treatment failure, and to use ctDNA as a future tool for response adapted therapy.
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ULYM20030 / ML41690 Polatuzumab / Patrick Reagan
Lead Researcher: Patrick Reagan
The purpose of this study is to test the effectiveness and safety of polatuzumab vedotin
in combination with R-miniCHP in patients 75 years and older with DLBCL.
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UMLT19186 / K08 JIT / Ramsdale
Lead Researcher: Erika Ramsdale
This is a single-site cluster-randomized trial to assess efficacy and implementation
outcomes of deprescribing interventions in 72 older adults with polypharmacy (PP)
and curable cancers initiating chemotherapy. Oncologists (as the cluster) will enroll
6 patients each and will be randomized to either a pharmacist-led deprescribing intervention
or patient education intervention. Initial focus groups with oncologists, nurses,
pharmacists, primary care physicians, and patients will provide data for initial adaptations
to the pharmacist-led intervention arm, and 8 patients will be enrolled as a pre-trial
cohort to further refine and adapt the pharmacist-led intervention.
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UMLT20123 / Van Veldhuizen / SMM & Prostate
Lead Researcher: Brea Lipe
To explore the use of curcumin and piperine supplementation at a dose of 4 gram/5mg
twice a day in early stage prostate cancer patient undergoing active surveillance
or patients on observation for MGUS/ low-risk smoldering myeloma.
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UMLYM23012 // 22-702 // Casulo
Lead Researcher: Danielle Wallace
The purpose of this study is to determine how effective and safe the combination of
rituximab and epcoritamab is in treating patients with Follicular Lymphoma (FL) and
who have not received other treatments for their lymphoma.
The names of the study drugs involved in this study are:
* Rituximab (a type of monoclonal antibody therapy)
* Epcoritamab (a T-cell bispecific antibody)
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UOCPC22008 / Triadic / Magnuson
Lead Researcher: Allison Magnuson
To gather key stakeholder input for feedback on the adaption of the COACH GA intervention
(i.e., develop COACH-Cog) to enhance triadic communication among oncologists, care
partners and patients with ADRD.
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UOCPC22010 / UR-GOAL 2 / Kah Poh Loh
Lead Researcher: Kah Poh Loh
The objective of this study is to conduct a pilot randomized trial to evaluate the
preliminary efficacy of the UR-GOAL tool vs. usual care in improving shared decision
making and communication between 100 older patients with AML and their oncologists.
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UOCPC22022 / E-Co Study / Kah Poh Loh
Lead Researcher: Kah Poh Loh
The objective of the study is to evaluate the feasibility of a combined mobile health
exercise and cognitive rehabilitation intervention and its effect on cognition in
a single-arm pilot study that recruits cancer survivors.
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UOCPC22065 / SONATA / Kah Poh Loh
Lead Researcher: Kah Poh Loh
The purpose of this study is to see if a social network support program (SOcial Networks
to Activate Trust \& Adherence or SONATA) is helpful for older individuals receiving
cancer treatment. The SONATA program will last for about 4 months. There are a total
of 6 coaching sessions. The first 5 sessions will be held approximately every 1 to
2 weeks. Session 6 or the final session will be held approximately 1 to 2 months after
session 5. Each session will last for about 1 to 2 hours.
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UOCPC23054 / GAM-CRT / Mohile
Lead Researcher: Supriya Mohile
This clinical trial tests how well a geriatric assessment (GA) with GA-directed treatment
recommendations, compared to GA with usual care, works in identifying risk factors,
reducing chemotherapy radiation toxicity and functional decline, and improving the
overall quality of life in older patients with non-small cell lung cancer (NSCLC).
Older patients with lung cancer undergoing chemotherapy are at an increased risk of
adverse outcomes including treatment toxicity and functional and physical consequences.
This makes it very challenging for the physicians to balance the benefits against
the risk of chemotherapy in older cancer patients. A geriatric assessment may be useful
in identifying risk factors for chemotherapy radiation toxicity. Communicating these
geriatric assessment findings and assessment-based recommendations to a patient's
treating physicians may help them make more informed decisions about treatment options
for patients. Making treatment decisions using GA-based recommendations may reduce
adverse events and improve outcomes in patients receiving treatment for NSCLC.
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UOCPC23082 / SCOPE / Loh
Lead Researcher: Kah Poh Loh
This research study is evaluating whether primary palliative care is an alternative
strategy to specialty palliative care for improving quality of life, symptoms, mood,
coping, and end of life outcomes in patients with acute myeloid leukemia (AML).
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URO105883/ADVANCED-1-Ph1b/2/Tabayoyong/RSRB8538
Lead Researcher: William Tabayoyong
This study is open-label dose expansion study to investigate the safety and toxicity
of intravesical treatment of high-grade NMIBC (HGTa or CIS, including CIS with concomitant
Ta) after transurethral resection of bladder tumor (TURBT) and/or biopsy using TARA-002
in adults unable to obtain intravesical Bacillus Calmette-Guérin (BCG), adults who
have received at least one dose of intravesical BCG or adults who have received at
least one dose of intravesical chemotherapy.
After completion of the dose escalation phase (Phase 1a) and after the RP2D has been
established, the dose expansion phase (Phase 1b) will start enrollment of subjects
with CIS NMIBC with active disease to further evaluate the safety and preliminary
efficacy of TARA-002, at the established RP2D. CIS NMIBC with active disease is defined
as disease present at the last cystoscopic evaluation prior to signing the ICF. Subjects
enrolled in the dose expansion phase will not include subjects previously enrolled
and treated in the dose escalation phase.
All subjects will receive 6 weeks of treatment at the established RP2D.
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Vaping/ Peter A. Wyman
Lead Researcher: Peter Wyman
Rates of adolescent vaping are increasing rapidly. Current high school student use
of electronic vaping products (EVPs) rose from 1.5% in 2011 to 20.8% in 2018 - an
increase from 220,000 to 3.05 million adolescent users. Effective, school-based interventions
are urgently needed to protect adolescents from initiating or continuing use of electronic
vaping products (EVPs). This study leverages a state-supported prevention initiative
to test the effectiveness of a promising intervention that trains 8th-9th grade student
peer leaders to deliver school-wide vaping prevention campaigns with ongoing adult
mentoring. If study hypotheses are supported, the study will provide the first evidence
of a school-based preventive intervention that reduces adolescent vaping behaviors,
as well as insight into how peer communications can be harnessed to prevent vaping.
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VAPOR 2 Study Pivotal Study Clinical Protocol/Frye/IUGUP23019
Lead Researcher: Thomas Frye
The purpose of this study is to evaluate the safety and efficacy of the Vanquish Water
Vapor Ablation Device ("Vanquish") in treating subjects with Gleason Grade Group 2
(GGG2) localized intermediate-risk prostate cancer.
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Vision Loss Impact due to Stroke on Steering when Driving
Lead Researcher: Krystel Huxlin
Stroke is the main cause of damage to the part of the brain that processes visual
information from the eyes. This can lead to vision loss even when there is no damage
to the eyes. The purpose of this research is to better understand how people compensate
for this type of vision loss by studying the steering behavior of people when driving.
Using a novel Virtual Reality (VR) program, we will gather data from people while
they drive in a simulated environment on the computer. If you are a resident of the
US or Canada, have a driver's license or have had a driver's license in the past,
and had a stroke that affected your vision when you were 21-80 years of age, you may
be eligible to participant.
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