The Caris Biorepository Research Protocol

Date Added
March 31st, 2026
PRO Number
Pro00149599
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer
Summary

The Caris Biorepository is collecting quality biospecimens, which can be any material that comes from human tissue, to bank for the purposes of future research studies related to advancing precision medicine and improving patient care. Select biospecimens may be collected from consenting individuals who have, or do not have cancer, are being screened for, or have an increased risk for a certain type of cancer. Samples may be used for research on: cells that make up your body (DNA and RNA) and how those cells and other cells work in healthy people and people with illness; how biomarkers might be able to predict the best treatments for a particular tumor type or blood finding; biomarker testing to discover and refine new technology; or, new discoveries and new biomarkers that can predict disease.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
balassom@musc.edu

The Caris Biorepository Research Protocol

Date Added
March 31st, 2026
PRO Number
Pro00149599
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer
Summary

The Caris Biorepository is collecting quality biospecimens, which can be any material that comes from human tissue, to bank for the purposes of future research studies related to advancing precision medicine and improving patient care. Select biospecimens may be collected from consenting individuals who have, or do not have cancer, are being screened for, or have an increased risk for a certain type of cancer. Samples may be used for research on: cells that make up your body (DNA and RNA) and how those cells and other cells work in healthy people and people with illness; how biomarkers might be able to predict the best treatments for a particular tumor type or blood finding; biomarker testing to discover and refine new technology; or, new discoveries and new biomarkers that can predict disease.

Institution
MUSC Health Kershaw Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
balassom@musc.edu

The Caris Biorepository Research Protocol

Date Added
March 31st, 2026
PRO Number
Pro00149599
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer
Summary

The Caris Biorepository is collecting quality biospecimens, which can be any material that comes from human tissue, to bank for the purposes of future research studies related to advancing precision medicine and improving patient care. Select biospecimens may be collected from consenting individuals who have, or do not have cancer, are being screened for, or have an increased risk for a certain type of cancer. Samples may be used for research on: cells that make up your body (DNA and RNA) and how those cells and other cells work in healthy people and people with illness; how biomarkers might be able to predict the best treatments for a particular tumor type or blood finding; biomarker testing to discover and refine new technology; or, new discoveries and new biomarkers that can predict disease.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
balassom@musc.edu

An Open-label, Phase 3 Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Vedolizumab Subcutaneous in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease Who Achieved Clinical Response Following Open-label Vedolizumab Intravenous Therapy

Date Added
April 1st, 2026
PRO Number
Pro00148307
Researcher
Carmine Suppa

List of Studies

Keywords
Crohn's Disease, Pediatrics, Ulcerative colitis
Summary

Efficacy of the vedolizumab IV and SC formulations has been demonstrated in completed studies of adult subjects with moderately to severely active UC or CD. Clinical trial results are needed to affirm proper dosing, exposure, efficacy and safety for use of vedolizumab in pediatric patients. Subsequent to preliminary positive results from the completed pediatric phase 2, vedolizumab IV is being further evaluated in the phase 3 Studies MLN0002-3024 and MLN0002-3025 (subjects aged 2 to 17 years). Confirmatory positive results from these studies would support submission for registration of vedolizumab IV for pediatric patients. Vedolizumab SC is being evaluated in the proposed study to provide an alternative administration route of vedolizumab for maintenance treatment in the
same pediatric population

Institution
MUSC
Recruitment Contact
Trudy Spuller
843-792-0560
spuller@musc.edu

Accelerating Translation to Practice: Multi-Level Interventions for Efficient Care Coordination Across Medical Specialties

Date Added
April 4th, 2026
PRO Number
Pro00150455
Researcher
Michelle Mollica

List of Studies


Keywords
Cancer/Breast, Cancer/Gastrointestinal, Cancer/Lung, Cancer/Other, Non-interventional
Summary

This research study aims to improve care coordination in the context of cancer survivorship care by understanding how primary care providers and cancer specialists share responsibilities. Researchers want to understand how technology can help these teams communicate more clearly and effectively to coordinate care for survivors. The study team will use surveys and conduct interviews and focus groups for interested and eligible participants as methods of data collection to inform the research. Oncologists, primary care physicians, and survivors of breast, prostate, lung, colon and rectal cancer that meet the eligibility criteria will complete surveys and engage in interviews to understand barriers and identify strategies to improve care. Using this information, the team will create an intervention plan called ACT that addresses common barriers, using focus group discussions to refine the intervention. The ultimate goal is to help patients receive better and more coordinated follow‑up care.

Institution
MUSC
Recruitment Contact
Mary Chris Pittman
843-792-3512
pittmama@musc.edu

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Zasocitinib in Pediatric Participants Aged 4 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis

Date Added
April 9th, 2026
PRO Number
Pro00149264
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

Zasocitinib (TAK-279) is an oral TYK2 inhibitor being studied as a potential treatment for moderate-to-severe plaque psoriasis in children and adolescents, a group with limited safe and effective oral options. TYK2 plays a crucial role in immune pathways involved in psoriasis, especially through IL-23's activation of Th17 cells and production of proinflammatory cytokines. Current treatments include injectable biologics and the oral agent apremilast, but few oral therapies match the efficacy of biologics. In phase 2b trials, zasocitinib showed promising results, with over two-thirds of adult participants achieving PASI-75 at certain doses by week 12 and no major safety concerns. Ongoing phase 3 trials are evaluating zasocitinib as a potential new oral treatment for pediatric plaque psoriasis.

Institution
MUSC
Recruitment Contact
Chadrick Schwipper
843-876-3209
schwippe@musc.edu

A Phase 1/2, Open-Label, Multi-Center, Dose Escalation, Dose Expansion, and Single Repeat Dose Study of TSRA-196 in Adults With the PiZZ Genotype Who Have Lung and/or Liver Disease Associated with Severe Alpha-1 Antitrypsin Deficiency

Date Added
April 9th, 2026
PRO Number
Pro00149000
Researcher
Charlie Strange

List of Studies


Keywords
Drug Studies, Liver, Lung, Pulmonary, Rare Diseases
Summary

This is a Phase 1/2, open-label, multi-center clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of TSRA-196, a gene editing compound, in adults with severe alpha-1 antitrypsin deficiency (PiZZ genotype) and associated lung and/or liver disease. Participants will receive a single intravenous dose of TSRA-196 in a dose-escalation phase followed by dose-expansion cohorts.

The study will assess safety outcomes, pharmacokinetics, and changes in serum alpha-1 antitrypsin levels and lung function to determine whether TSRA-196 can safely increase functional AAT levels and inform selection of an appropriate dose for further clinical development.

Institution
MUSC
Recruitment Contact
Kristin Neff
843-792-1219
neffk@musc.edu

The Impact of Toxic Exposures on Vascular Autoantibodies in Lupus Associated Cardiovascular Disease

Date Added
April 10th, 2026
PRO Number
Pro00147299
Researcher
Helen Butler

List of Studies

Keywords
Cardiovascular, Lupus
Summary

The purpose of this study is to understand how exposure to harmful substances during military service may affect the health of Veterans with or without lupus. Lupus is an autoimmune disease that can increase the risk of cardiovascular problems.

We believe that Veterans who were exposed to toxic substances during their military service may develop more harmful antibodies that attack the lining of their blood vessels. These antibodies may contribute to poorer blood vessel and heart health, and could contribute to the development of lupus.

This study aims to improve our understanding of how toxic military exposures may increase the risk of blood vessel complications in Veterans with and without lupus. Ultimately, this research may help identify new ways to better prevent, monitor, or treat cardiovascular disease in this population.

Research procedures for this study will include:

1. The study team will check subject medical records to gather information about medical history and medications being taking. The study team may continue to follow updates in the medical record.
2. Subjects will be given a survey to assess military and occupational toxic inhalant exposures.
3. Subjects will have a brief physical examination during which vitals will be recorded (height, weight, heart rate, respiration, temperature). Women of childbearing ages will be asked for the date of their last menstrual cycle within the past 2 months.
4. Subjects will have blood pressure taken three times three minutes apart.
5. Subjects will then provide a urine sample. Urine collection will occur in a private restroom using a sterile container provided by the study team. For women of childbearing ages, a pregnancy dipstick test will be undertaken on urine to confirm subjects are not pregnant.
6. Subjects will undergo a blood draw where approximately 4 teaspoons of blood will be drawn.

Institution
MUSC
Recruitment Contact
Helen Butler
7046540686
butlehel@musc.edu

A Multi-Center Screening Study to Characterize the Prevalence of the KIT D816V Mutation in Patients with Suspected Clonal Mast Cell Disease

Date Added
April 15th, 2026
PRO Number
Pro00149043
Researcher
Alexander Coltoff

List of Studies

Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for participants with symptoms of mast cell activation (SMAC). The primary purpose of this study is to learn about clonal mast cell diseases. Clonal mast cell diseases are hard to diagnose because symptoms are not specific, and they can overlap with other diseases. The tools currently used by doctors to look for clonal mast cell diseases in the blood may not identify all patients. This study is being done to develop an investigational blood test that looks for a change in a gene called KIT. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). Two types of blood tests will be compared against each other. Participants in this study can expect to be in this study for about 6 months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinicaltrials@musc.edu

A Phase III Study of Induction Pembrolizumab and Chemotherapy Followed by Chemoradiation and Pembrolizumab vs Chemoradiation and Pembrolizumab Both Followed by Pembrolizumab for High Risk Locally Advanced Cervical Cancer

Date Added
April 16th, 2026
PRO Number
Pro00150355
Researcher
Brian Orr

List of Studies

Keywords
Cancer, Cancer/Gynecological, Drug Studies, Women's Health
Summary

This study is for patients that have been diagnosed with squamous cell, adenocarcinoma, or adenosquamous cervical cancer. This study is testing an investigational drug called pembrolizumab. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). A computer will be used to assign you to one of the study groups. This process is called "randomization." Like flipping a coin, everyone has an equal chance of being placed in any group. The primary purpose of this study is to determine whether induction immunotherapy (IO) and chemotherapy prior to concurrent chemoradiotherapy plus immunotherapy (CCRT+IO) improves progression-free survival (PFS) compared to CCRT+IO alone. The study drug is given by infusion. Participants in this study can expect to be on the study for 7 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinicaltrials@musc.edu



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