SPECIMEN COLLECTION FROM PARTICIPANTS DUE FOR COLORECTAL CANCER SCREENING, SURVEILLANCE, OR TREATMENT: "IMPACT"

Date Added
August 27th, 2025
PRO Number
Pro00143588
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal
Summary

The purpose of the study is to help to develop a new test that may help with early colorectal cancer detection. This will be done by collecting a blood sample, a stool sample, and other sample types, and comparing the results to hopefully identify a biomarker that can detect cancer more easily than current standards.

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

SPECIMEN COLLECTION FROM PARTICIPANTS DUE FOR COLORECTAL CANCER SCREENING, SURVEILLANCE, OR TREATMENT: "IMPACT"

Date Added
August 27th, 2025
PRO Number
Pro00143588
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal
Summary

The purpose of the study is to help to develop a new test that may help with early colorectal cancer detection. This will be done by collecting a blood sample, a stool sample, and other sample types, and comparing the results to hopefully identify a biomarker that can detect cancer more easily than current standards.

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

Quantification of phosphorylated alpha-synuclein in patients with Parkinson's disease and REM sleep behavior disorder (Syn-Q)

Date Added
August 27th, 2025
PRO Number
Pro00143143
Researcher
Christine Cooper

List of Studies


Keywords
Parkinsons
Summary

This study aims to study the natural progression of P-SYN quantification by conducting skin biopsies in patients with Parkinson's Disease (PD) and REM sleep behavior disorder (RBD). Participation will be over an 18-month period and will include skin biopsies and clinical examinations every six months. Subjects will be male or female between the ages of 50-100 and have a diagnosis of PD or RBD.

Institution
MUSC
Recruitment Contact
Sandra Wilson
8437924616
MovementResearch@musc.edu

Fostering Healthy Relationships through Tele-PCIT for Families of South Carolina

Date Added
August 24th, 2025
PRO Number
Pro00146035
Researcher
Rosmary Ros-Demarize

List of Studies


Keywords
Children's Health, Pediatrics
Summary

The purpose of this research study is to evaluate Parent Child Interaction Therapy (PCIT) delivered via tele-health for young children with disruptive behavior problems who are at risk for life stressors. Participants will go through a screening to determine eligibility. Once screening is complete, eligible families who choose to participate will complete questionnaires, 3 virtual visits, and will receive 10 tele-health therapy sessions, at no cost. Families will be compensated for their time.

El propósito de este estudio de investigación es evaluar la Terapia de la Interacción Padre-Hijo (PCIT, por sus siglas en inglés) mediante telesalud para niños pequeños con dificultades de comportamiento que están en riesgo de factores de estrés en la vida. Los participantes pasarán un cernimiento para determinar su elegibilidad. Una vez que se complete, las familias elegibles que decidan participar completarán cuestionarios, 3 visitas virtuales y recibirán 10 sesiones de terapia por telesalud, que serán gratuitas. Las familias recibirán compensación por su tiempo.

Institution
MUSC
Recruitment Contact
Franchesca Araya
843-714-1352
pcitfamilias@musc.edu

A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa: Topical Ruxolitinib Evaluation in Hidradenitis Suppurativa (TRuE-HS1)

Date Added
August 21st, 2025
PRO Number
Pro00144283
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

The primary purpose of this study is to assess the efficacy and safety of ruxolitinib 1.5% cream applied twice daily in participants with mild to moderate HS (Hurley Stage I or II) without draining tunnels.

Institution
MUSC
Recruitment Contact
Kennedy McLeod
8437924091
mcleodke@musc.edu

An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients with Schizophrenia, Bipolar Disorder, or Autism Spectrum Disorder

Date Added
August 21st, 2025
PRO Number
Pro00140167
Researcher
Thomas Uhde

List of Studies


Keywords
Autism
Summary

Currently, there are no FDA-approved medications for the treatment of irritability associated with Autism Spectrum Disorder (ASD). This study is designed to look at the usefulness and safety of lumateperone (CAPLYTA) for the treatment of irritability associated with ASD among pediatric participants between the ages of 5 to 17 years. The study will last approximately 26 weeks and the participants will receive the study drug, lumateperone.

Institution
MUSC
Recruitment Contact
Jelissa Suarez
843-876-9262
suarezj@musc.edu

A Randomized Phase II Study of Venetoclax and HMA-based Therapies for theTreatment of Older and Unfit Adults With Newly Diagnosed for FLT-3 Mutated Acute Myeloid Leukemia (AML): a MyeloMATCH Treatment Trial

Date Added
August 19th, 2025
PRO Number
Pro00146654
Researcher
Praneeth Baratam

List of Studies

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

This phase 2 study is enrolling patients who have acute myeloid leukemia (AML) with certain biomarkers. This study is being done to see the effectiveness of different combinations of drugs to treat AML. It will involve 3 groups of patients receiving different combinations of Gilteritinib, Azacitidine and Venetoclax. Gilteritinib is an investigational drug, Azacitidine and Venetoclax are FDA approved. The main purpose of the study is to see if the amount of leukemia in the patient's body can be lowered by adding the drug Gilteritinib to the Standard of Care of treating AML with Azacitidine and Venetoclax. The study will include approximately 147 patients. The patients will be randomized into the three groups (like flipping a coin), Group 1 will receive just Azacitidine + Venetoclax, Groups 2 and 3 will also receive Gilteritinib but Group 2 will receive it for more time within a treatment cycle. Patients will complete screening after participating in this treatment trial or SOC therapies. Patients will continue treatment until disease progression, unacceptable toxicity, study closure, death, or withdrawal of consent. The main risk is that the study drugs may not be as good as the usual approach for their cancer or condition at shrinking or stabilizing their cancer. Patients may have none, some, or all of the side effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit for them in participating in this study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

PHASE II STUDY EVALUATING NALIRIFOX VS. MODIFIED GEMCITABINE, NAB-PACLITAXEL, AND CISPLATIN IN PATIENTS WITH LOCALLY ADVANCED AND METASTATIC PANCREATIC ADENOCARCINOMA

Date Added
August 19th, 2025
PRO Number
Pro00145838
Researcher
Toros Dincman

List of Studies

Keywords
Cancer, Cancer/Gastrointestinal, Cancer/Other, Drug Studies, Pancreas
Summary

This study is for patients that have been diagnosed with previously untreated, locally advanced, and metastatic pancreatic ductal adenocarcinoma PDAC. This study is testing two treatment regimens: NALIRIFOX (5-fluorouracil, liposomal irinotecan, oxaliplatin, and leucovorin) vs mGAP (gemcitabine, nab-paclitaxel, and cisplatin).
The primary purpose of this study is to see which of the two regimens is more effective in PDAC. Participants will continue on study medications if seeing clinical benefit, and can expect to be on the study for a maximum of 6 months.

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

Utilizing sFLT-1/PLGF Ratios to Differentiate and Predict Deterioration in Growth-Restricted Fetuses

Date Added
August 15th, 2025
PRO Number
Pro00144214
Researcher
Amartha Gore

List of Studies

Keywords
Obstetrics and Gynecology
Summary

This a blood draw study. Blood samples will be collected every 4 weeks on women diagnosed with fetal growth restriction. We hope it will help to determine other ways to evaluate patients with fetal growth restriction and thus improve outcomes.

Institution
MUSC
Recruitment Contact
Jesslyn Payne
843-792-7525
paynej@musc.edu

CARDIOVASCULAR INFECTION DIAGNOSIS USING METAGENOMICS AND PREDICTING APPROACH TO APPROPRIATE CLINICAL TESTING: THE IMPACT STUDY

Date Added
August 13th, 2025
PRO Number
Pro00144819
Researcher
Courtney Harris

List of Studies

Keywords
Cardiovascular, Infectious Diseases
Summary

To describe current real-world utilization of mcfDNA testing for CV infections using a multi-center retrospective registry. We will develop multi-center REDCap database of mcfDNA use in valvular IE and/or CIED lead infections and summarize patient demographics and clinical characteristics of IE and CIED lead infection cases. We will assess common scenarios/indications for which mcfDNA is sent and timing of the test. Clinically relevant microbiological yield of mcfDNA in IE and/or CIED lead infections will be described.

To identify clinical predictors where mcfDNA outperforms CMT. We will assess clinical characteristics of patients with IE and CIED lead infection in whom mcfDNA has higher microbiologic yield compared to CMT. We will develop a prediction model/scoring system to identify subgroup of patients in whom mcfDNA should be sent early (after 48 hours of negative CMT).

To analyze clinical impact of mcfDNA testing in patients with valvular IE and/or CIED lead infections. We will classify cases as having Positive vs. Negative vs. Neutral impact using pre-specified definitions and assess predictor of positive clinical impact.

Institution
MUSC
Recruitment Contact
Courtney Harris
8437924549
harricou@musc.edu



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