GAIN-BCG: Gemcitabine Alternating With Intravesical BCG Randomized Against BCG Alone For Patients With Recurrent High Grade Non-Muscle Invasive Bladder Cancer

Date Added
October 28th, 2025
PRO Number
Pro00147104
Researcher
Robert Grubb

List of Studies


Keywords
Cancer/Genitourinary, Drug Studies
Summary

This study is for people with high-risk, non-muscle invasive bladder cancer that has returned after treatment with BCG. Your cancer either did not fully respond to BCG or came back after initially responding, which is called BCG-exposed NMIBC. The purpose of this study is to find out if adding a chemotherapy drug called gemcitabine, given directly into the bladder through a catheter, to BCG works better than BCG alone. In this study, you will either receive BCG alone for up to 6 weeks or gemcitabine plus BCG for up to 10 weeks, called induction therapy. If the treatment is effective, you may continue with maintenance therapy, which is either BCG alone or gemcitabine plus BCG given over several weeks. After treatment, your doctor will monitor you for 5 years with regular checkups, cystoscopies, and CT scans to watch for side effects or recurrence. The main risks are that the study treatment may not work as well as usual care, and it may cause side effects such as pain with urination, urinary urgency, blood in the urine, bladder inflammation, or urinary tract infection. There may also be risks that study doctors do not yet know about.
There will be a total of 17 patients enrolled locally over the course of 42 months.

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

A Multi-Center, Prospective, Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients with Ulcerative Colitis

Date Added
October 23rd, 2025
PRO Number
Pro00147432
Researcher
Erin Forster

List of Studies


Keywords
Ulcerative colitis
Summary

The goal is to evaluate how well etrasimod helps reduce symptoms by week 12 of treatment. This involves determining whether patients experience enough improvement to be considered in remission. The focus is on how the medication performs in everyday, real-world conditions.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Protocol S2414, A Randomized Phase III Trial Incorporating Pathologic Complete Response in Participants with Early Stage Non-Small Cell Lung Cancer to Optimize Immunotherapy in the Adjuvant Setting (INSIGHT) (NCT06498635)

Date Added
October 22nd, 2025
PRO Number
Pro00147635
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung
Summary

This phase III trial compares durvalumab to the usual approach (patient observation) after surgery for the treatment of patients with early-stage non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients who are not in a study is to closely watch a patient's condition after surgery and to have regular visits with their doctor to watch for signs of the cancer coming back. Usually, patients do not receive further treatment unless the cancer returns. This study will help determine whether this different approach with durvalumab is better, the same, or worse than the usual approach of observation. Giving durvalumab may help patients live longer and prevent early-stage non-small cell lung cancer from coming back as compared to the usual approach.

Institution
MUSC
Recruitment Contact
maggie bentley
864-725-7125
margaret.bentley@selfregional.org

Brain Metastases in Greater Size - Hypofractionated Options Trial (BIGSHOT)

Date Added
October 21st, 2025
PRO Number
Pro00146438
Researcher
Charlotte Rivers

List of Studies


Keywords
Cancer/Brain
Summary

This study is for adult patients with large brain metastases. The purpose of this study is to compare two different radiation therapy dose treatments: staged stereotactic radiosurgery (SSRS) and fractionated stereotactic radiotherapy (FSRT). Both treatment options are currently used as standard of care. Participation in this study will include standard of care visits along with questionnaires completed for research purposes.

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

Clinical Characteristics, Treatment Patterns and Outcomes in Patients with Alopecia Areata Following Initiation of Ritlecitinib, Baricitinib or Standard of Care Treatment.

Date Added
October 17th, 2025
PRO Number
Pro00146871
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This study is a non-interventional, multicenter investigation of patient outcomes, combining a retrospective medical chart review with prospective patient questionnaires. It focuses on patients receiving ritlecitinib, baricitinib, or standard of care (SOC) treatment for alopecia areata (AA). Prospective data will be collected over 12 months following the start of treatment. The study aims to enroll 300 adults (aged 18 and older) and 100 adolescents/minors (aged 12-17) from 20-25 sites across the USA. Among the adult participants, 100 will receive ritlecitinib, 100 baricitinib, and 100 SOC. The adolescent/minor group will include 50 receiving ritlecitinib and 50 SOC.

Institution
MUSC
Recruitment Contact
Kenreka Yeadon
843-876-0110
yeadon@musc.edu

A Pilot Study to Assess the Effects of Simeox 200 Airway Clearance Device in Bronchiectasis Patients with Chronic Mucus Hypersecretion

Date Added
October 14th, 2025
PRO Number
Pro00147345
Researcher
Patrick Flume

List of Studies


Keywords
Bronchiectasis, Lung
Summary

This will be a study in the home care setting to further validate the concept of Simeox 200 in a cohort of patients with bronchiectasis and overproduction of mucous as an alternative to other methods of ACT(airway clearance techniques). Bronchiectasis is a chronic lung disease where airways become permanently damaged, widened, and lose their ability to clear mucus, leading to a buildup of bacteria, recurrent infections, and symptoms like a daily cough, thick, discolored phlegm, shortness of breath, and fatigue. The device is a 510(k) FDA cleared device that works using by air and vibration to help clear mucous from the lungs. There are 4 visits and an at home usage period. The study will be running approximately a year or until the cohort is filled. The data from this study will be used to power a future randomized controlled pivotal clinical study comparing Simeox 200 against other ACTs such as High Frequency Chest Wall Oscillation (HFCWO).

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A PHASE 1 STUDY EVALUATING THE SAFETY AND PRELIMINARY EFFICACY OF ALLO-329, A DUAL ANTI-CD19 / ANTI-CD70 ALLOGENEIC CAR T CELL PRODUCT IN AUTOIMMUNE DISEASE (RESOLUTION)

Date Added
October 14th, 2025
PRO Number
Pro00145211
Researcher
Melissa Cunningham

List of Studies


Keywords
Autoimmune disease, Lupus
Summary

This study will look at how safe and effective the study drug, ALLO-329, is for people with autoimmune diseases like lupus. Participants will get one dose through an IV. The goal is to find the safest amount of the treatment that could help people stay in remission longer.

Institution
MUSC
Recruitment Contact
Stephanie Dezzutti
(843) 792-8997
brays@musc.edu

A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 versus Investigator's Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge

Date Added
October 8th, 2025
PRO Number
Pro00144193
Researcher
Theodore Gourdin

List of Studies


Keywords
Cancer/Genitourinary, Drug Studies, Men's Health, Prostate
Summary

This study is for male subjects that have been diagnosed with metastatic prostate cancer (that has spread to other parts of the body) and progressed following standard hormonal/radiation therapy and surgery. Subjects are expected to remain in the study for a minimum of 48months or longer. There will be a total of 10 subjects locally enrolled.

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

Accelerated High-Dose tDCS for Depression: An Open-Label Outpatient Pilot Study

Date Added
October 7th, 2025
PRO Number
Pro00146983
Researcher
Mark George

List of Studies


Keywords
Depression, Nervous System
Summary

In this study, we are testing whether a higher dose of a non-invasive brain stimulation technique, called transcranial direct current stimulation (tDCS), can be safely used in people with depression. Participants will come to the Brain Stimulation Lab and receive mild electrical stimulation through electrodes placed on their scalp.

The study begins with a safety run-in, where the first few participants will receive stimulation at gradually increasing levels (2, 4, and 6 milliamps) while being closely monitored. If no serious side effects are found, later participants will receive repeated 6 milliamp sessions for 5 days total. We will check skin comfort, mood, and overall tolerability after each session.

Institution
MUSC
Recruitment Contact
Clayton Olash
843-243-7305
olash@musc.edu

A Prospective Multicenter Single-arm Clinical Study Investigating Clinical Outcomes when Cohealyx™ is used for the Management of Full Thickness Wounds Post-surgical Excision

Date Added
October 7th, 2025
PRO Number
Pro00146533
Researcher
Steven Kahn

List of Studies


Keywords
Surgery
Summary

This is a prospective single-arm post-market multicenter study to evaluate
clinical outcomes of Cohealyx when used to manage full thickness wounds
post-surgical excision. Patients with a full thickness wound where autografting is clinically indicated will be considered for participation in this study. Patients will
undergo a staged surgical procedure for wound closure. In the first surgery, Cohealyx will be applied to the surgically excised wound bed within 5-days post-injury. Once Cohealyx has successfully integrated into the wound bed, the wound will be prepped and autografted per standard of care.

Institution
MUSC
Recruitment Contact
Deanna DeHoff
843-792-8522
dehoff@musc.edu



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