A Phase III, Multicenter, Open-label Study of Ribociclib vs. Palbociclib in Patients With Advanced Hormone Receptor-positive/HER2-negative/HER2-Enriched Breast Cancer - HARMONIA Trial

Date Added
August 2nd, 2023
PRO Number
Pro00128890
Researcher
Frank Brescia

List of Studies


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

The study is for patients that have been diagnosed with with a certain type of breast cancer, characterized as HER2 (Human Epidermal Growth Factor Receptor 2)-negative and hormonal receptor (HR)-positive, and with a specific characteristic (molecular subtype) called HeER2-Enriched. The investigational drugs used in this study are Ribociclib and Palbociclib. The main purpose of this study is to learn determine if participants with the specific HER2-Enriched subtype will have delayed progression of the disease when treated with ribociclib compared to palbociclib. Participants can expect to be in this study for up to 5 years.

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

A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Prurigo Nodularis

Date Added
August 2nd, 2023
PRO Number
Pro00128776
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

The purpose of this research study is to determine if an investigational cream, ruxolitinib 1.5% cream, is safe and effective to treat adults with prurigo nodularis. In this study, ruxolitinib cream will be compared to a "vehicle cream." The vehicle cream looks like the ruxolitinib cream but contains no ruxolitinib. This study can last up to 60 weeks, including up to 4 weeks for screening, up to 52 weeks for treatment, and 30 days for safety follow-up. Eligible participants will be randomized 1:1 to receive ruxolitinib 1.5% cream or vehicle cream for the first 12 weeks. For the following 40 weeks all participants will receive the ruxolitinib cream.

Institution
MUSC
Recruitment Contact
Tiffany Vereen
843-792-6882
vereent@musc.edu

Randomized Phase II/III Trial of First Line Platinum/Etoposide with or without Atezolizumab (NSC #783608) in Patients with Advanced or Metastatic Poorly Differentiated Extrapulmonary Neuroendocrine Carcinomas (NEC)

Date Added
July 30th, 2023
PRO Number
Pro00129939
Researcher
Paul O'Brien

List of Studies


Keywords
Cancer/Gastrointestinal, Cancer/Genitourinary
Summary

This study is for patients with neuroendocrine carcinoma (NEC) originating outside of the lung. This study is being done to see if the combination of atezolizumab, an immunotherapy drug, with a platinum drug (cisplatin or carboplatin) and etoposide better or worse than a platinum drug and etoposide for patients with advance or metastatic neuroendocrine carcinoma originating outside the lung

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

Thrombophilia in Embolic stroke of undetermined source (ESUS)

Date Added
July 27th, 2023
PRO Number
Pro00127326
Researcher
Ghada Mohamed

List of Studies

Keywords
Brain
Summary

The purpose of this research study is to study the utility of advanced blood testing for patients who have had a stroke and tend to form blood clots more than usual. The study involves blood tests using a new testing system that may detect issues with blood clotting easier than conventional tests. This is a 12-month study and will involve one blood draw and follow-up phone calls

Institution
MUSC
Recruitment Contact
There is no research coordinator
3134180214
mohamedg@musc.edu

Characterization of barriers and facilitators of guideline concordant extended venous thromboembolism prophylaxis after major cancer surgery

Date Added
July 26th, 2023
PRO Number
Pro00127734
Researcher
Thomas Curran

List of Studies


Keywords
Bowel, Cancer/Gastrointestinal, Surgery
Summary

While blood clots after major cancer surgery are common and harmful to patients, the medications available to decrease blood clot risk are seldom used despite the recommendation of multiple professional medical societies. The reasons why these medications are seldom prescribed is not well understood. We aim to characterize barriers and facilitators to extended blood clot prophylaxis guideline adherence as perceived by stakeholders via interviews with a diverse group of patients and surgeons at hospitals within the MUSC Health system that routinely perform cancer surgery. These findings will inform educational interventions to improve the use of guideline concordant care and mitigate observed disparities in cancer care.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Natalie Koren
843-792-0109
korenn@musc.edu

Characterization of barriers and facilitators of guideline concordant extended venous thromboembolism prophylaxis after major cancer surgery

Date Added
July 26th, 2023
PRO Number
Pro00127734
Researcher
Thomas Curran

List of Studies


Keywords
Bowel, Cancer/Gastrointestinal, Surgery
Summary

While blood clots after major cancer surgery are common and harmful to patients, the medications available to decrease blood clot risk are seldom used despite the recommendation of multiple professional medical societies. The reasons why these medications are seldom prescribed is not well understood. We aim to characterize barriers and facilitators to extended blood clot prophylaxis guideline adherence as perceived by stakeholders via interviews with a diverse group of patients and surgeons at hospitals within the MUSC Health system that routinely perform cancer surgery. These findings will inform educational interventions to improve the use of guideline concordant care and mitigate observed disparities in cancer care.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Natalie Koren
843-792-0109
korenn@musc.edu

Characterization of barriers and facilitators of guideline concordant extended venous thromboembolism prophylaxis after major cancer surgery

Date Added
July 26th, 2023
PRO Number
Pro00127734
Researcher
Thomas Curran

List of Studies


Keywords
Bowel, Cancer/Gastrointestinal, Surgery
Summary

While blood clots after major cancer surgery are common and harmful to patients, the medications available to decrease blood clot risk are seldom used despite the recommendation of multiple professional medical societies. The reasons why these medications are seldom prescribed is not well understood. We aim to characterize barriers and facilitators to extended blood clot prophylaxis guideline adherence as perceived by stakeholders via interviews with a diverse group of patients and surgeons at hospitals within the MUSC Health system that routinely perform cancer surgery. These findings will inform educational interventions to improve the use of guideline concordant care and mitigate observed disparities in cancer care.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Natalie Koren
843-792-0109
korenn@musc.edu

Characterization of barriers and facilitators of guideline concordant extended venous thromboembolism prophylaxis after major cancer surgery

Date Added
July 26th, 2023
PRO Number
Pro00127734
Researcher
Thomas Curran

List of Studies


Keywords
Bowel, Cancer/Gastrointestinal, Surgery
Summary

While blood clots after major cancer surgery are common and harmful to patients, the medications available to decrease blood clot risk are seldom used despite the recommendation of multiple professional medical societies. The reasons why these medications are seldom prescribed is not well understood. We aim to characterize barriers and facilitators to extended blood clot prophylaxis guideline adherence as perceived by stakeholders via interviews with a diverse group of patients and surgeons at hospitals within the MUSC Health system that routinely perform cancer surgery. These findings will inform educational interventions to improve the use of guideline concordant care and mitigate observed disparities in cancer care.

Institution
MUSC
Recruitment Contact
Natalie Koren
843-792-0109
korenn@musc.edu

A Randomized Phase II Study of INC280 (Capmatinib) plus Osimertinib with or without Ramucirumab in Participants with EGFR-Mutant, MET-Amplified Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)

Date Added
July 19th, 2023
PRO Number
Pro00130230
Researcher
Christopher Rangel

List of Studies

Keywords
Cancer/Lung
Summary

This study is for patients who have advanced non-small cell lung cancer who in addition to the EGFR gene change (mutation) that was previously found in their tumor, testing found that their tumor also now has MET gene changes. The study is checking to see if a combination of 3 targeted drugs work together to lower the chance of lung cancer growing or spreading.

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

Effects of Chronic Systolic Heart Failure on Skeletal Muscle Structure and Function in Patients Undergoing Heart Transplant or Left Ventricular Assist Device Placement

Date Added
July 18th, 2023
PRO Number
Pro00128583
Researcher
Michele Esposito

List of Studies

Keywords
Healthy Volunteer Studies
Summary

Patients with end stage heart failure (HF) exhibit abnormalities in their skeletal muscle, thought to be as a result of reduced blood flow to the muscle as their HF severity worsens. We will identify the relative nature of these changes by obtaining skeletal muscle biopsies in these patients prior to surgery (either heart transplant or implant of a surgical heart bypass machine). These biopsies will be from the upper thigh as well as from the calf muscle. We will compare these biopsies to each other in each patient to identify if the changes we are seeing are in fact more severe in the distal (calf) muscle.

Institution
MUSC
Recruitment Contact
Renee Baxley
843-792-1105
baxleyr@musc.edu



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