Neuroendocrine Tumors Patient Reported Outcomes (NET-PRO)

Date Added
August 23rd, 2022
PRO Number
Pro00120896
Researcher
William Lancaster

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal, Cancer/Lung
Summary

The purpose of this research study is to gain patient feedback around their Neuroendocrine tumor (NET) diagnosis, including symptoms and quality of life with different NET treatments, factors that influence the order of treatments given, and how the order of NET treatments affect patient's quality of life, symptoms and survival. The main eligibility criteria for this study are being 18 or older and receiving the diagnosis of a neuroendocrine tumor on or after January 1st, 2019. Participation will last about 18 months, involving the completion of four electronic or paper surveys spaced six months apart. The first survey will take about 40 minutes to complete, while the other three surveys may take about 20 minutes each to complete. Participants will be compensated for their time and participation in this research study.

Institution
MUSC
Recruitment Contact
Eryn Beal
(843) 792-7011
bealery@musc.edu

PREvention of CardIovascular and DiabEtic kidNey disease in Type 2 Diabetes

Date Added
August 17th, 2022
PRO Number
Pro00122367
Researcher
Harsha Karanchi

List of Studies


Keywords
Diabetes, Drug Studies, Heart, Kidney
Summary

This study will involve taking one or two medications already approved by the Food and Drug Administration (FDA) for treatment of type 2 diabetes to learn more about which diabetes medications are the best for lowering the risk of heart and kidney disease in individuals with type 2 diabetes who are at least 40 years old. Participation includes about 8 study visits over a period of 72 months, which can be performed over the phone remotely or during normal standard of care clinic visits. Participants will be compensated for their time and participation in this research study.

Institution
MUSC
Recruitment Contact
Elizabeth Szwast
(843)-792-4675
hinsone@musc.edu

A Phase 1B Dose Escalation Study Of Metabolically Fit CD19 Chimeric Antigen Receptor (CAR) T Cells With CD34 Selection Markers In Adult Patients With Relapsed Or Refractory CD19 B- Cell Non-Hodgkin Lymphoma And Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Date Added
August 16th, 2022
PRO Number
Pro00121846
Researcher
Brian Hess

List of Studies


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

This study is for adult male and female subjects that have been diagnosed with B-cell leukemias and lymphomas. In this research study, some of the subjects immune cells (called T cells) will be taken during a procedure called ‘apheresis', and genetically modified in the laboratory, in order to recognize a protein on the cancer cells. The investigational treatment in this study is called CD19-CD34t metabolically programmed CAR-T cells. The purpose of this study is to test whether these genetically CD19-CD34 CAR T-cells when re-introduced back into the body, will be able to safely and effectively attack the cancer cells. The investigators also want to determine the dose of genetically modified CD19-CD34 CAR T-cells which can be safely administered to subjects. Subjects can expect to be in this study for up to 15 years.

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

ACCESS: A Multi-Center, Phase II Trial of HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation with Post-Transplantation Cyclophosphamide for Patients with Hematologic Malignancies.

Date Added
August 16th, 2022
PRO Number
Pro00118834
Researcher
Michelle Hudspeth

List of Studies


Keywords
Adolescents, Cancer, Pediatrics, Transplant
Summary

This study is for patients that have had hematopoietic stem cell transplants and/or have been donors. The purpose of this study is to see how well transplant works in adults with a MMUD using stem cells from a donor's blood, and in children with a MMUD using stem cells from a donor's bone marrow.This study treatment does not include any investigational drugs. The medicines and procedures in this study are standard for transplant. Participants can expect to be on this study for approximately 1 year.

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

MEPITEL FILM FOR THE REDUCTION OF RADIATION DERMATITIS IN BREAST CANCER PATIENTS UNDERGOING POST-MASTECTOMY RADIATION THERAPY: A RANDOMIZED PHASE III CLINICAL TRIAL

Date Added
August 15th, 2022
PRO Number
Pro00122724
Researcher
Jennifer Harper

List of Studies


Keywords
Cancer/Breast
Summary

This study is for patients who have been diagnosed with breast cancer and their doctor has recommended that they receive radiation therapy after their mastectomy to reduce the risk of their breast cancer coming back. This study is being done to see if the severity of skin redness and peeling in the area of radiation can be reduced by applying Mepitel Film during radiation therapy.

Institution
MUSC
Recruitment Contact
Barbara Roe
843-652-1607
broe@tidelandshealth.org

A Randomized, Double-blind, Placebo-controlled Phase 2 Study with Open-label Extension to Assess the Efficacy and Safety of Namilumab in Subjects with Chronic Pulmonary Sarcoidosis.

Date Added
August 10th, 2022
PRO Number
Pro00121050
Researcher
Walter James

List of Studies


Keywords
Sarcoidosis
Summary

The primary objective of this study is to evaluate the efficacy of namilumab in subjects with chronic pulmonary sarcoidosis (CPS). This study will include adult subjects who have been diagnosed with CPS for more than 6 months who are not well controlled by OCS and/or immunosuppressive therapy (IST). 100 total subjects are planned for this study. There will be a Double-blind treatment period of this study lasting approximately 26 weeks as well as an optional Open-Label Extension (OLE) Treatment Period which will extend the length of the study to approximately 64 weeks.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-0965
shannonz@musc.edu

The ASCEND Trial: A Multicenter, Double Blinded Vehicle Controlled Study of TMB-001, a Proprietary Isotretinoin Ointment, in the Treatment of RXLI (X-linked) or ARCI (Lamellar) Ichthyosis; Preceded by a Voluntary Maximal Use Study; Both Studies in Subjects 6 Years of Age and Above

Date Added
August 10th, 2022
PRO Number
Pro00120937
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Drug Studies, Pediatrics, Skin
Summary

This study aims to evaluate the safety and efficacy of isotretinoin ointment (TMB-001 0.05%) in treating subjects > or = to 6 years of age with lamellar ichthyosis, and aims to assess the bodily absorption of the cream across application frequencies. Subjects with ARCI/RXLI will be randomized 2:1, to either receive the TMB-001 0.05% isotretinoin ointment or a vehicle ointment - applied daily - for 3 weeks. Subsequently, dosing will be increased to twice daily for 9 weeks. If significant improvement is observed at the end of the 9 weeks, subjects will be randomized 1:1 to receive the TMB-001 0.05% ointment, either applied daily or twice-daily, for 12 weeks. Prior to the Phase III trial, subjects will have the option to participate in a 14 day treatment period with TMB-001 0.05% - twice daily - followed by continued treatment with TMB-001 0.05% twice daily for 10 weeks.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-9784
rowle@musc.edu

Fluid management of Acute decompensated heart failure Subjects Treated with Reprieve Decongestion Management System (DMS)

Date Added
August 9th, 2022
PRO Number
Pro00120551
Researcher
Chakradhari Inampudi

List of Studies

Keywords
Drug Studies, Heart
Summary

This study will enroll participants who are hospitalized with decompensated heart failure. Heart failure is a condition in which the heart is not able to pump blood efficiently and as a result fluid can build up. This study is testing an investigational, not yet approved for commercial use by the Food and Drug Administration (FDA) device called the Repreive DMS. The Repreive DMS is an instrument designed to automatically administer medications called diuretics to optimize fluid removal and improve your symptoms of heart failure. This study has a randomized arm in which participants will be randomly assigned to treatment with the Repreive DMS system or standard of care treatment referred to as Optimal Diuretic Therapy. You have a 50:50 chance of being assigned to either arm. There is also a registry arm for participants who do not wish to participate in the randomized part of the study. The registry involves collecting data from your standard treatment. The randomized study will last about 13 weeks and involved up to 9 visits. The Repreive DMS involves infusing medication through an IV (intravenous or in the vein) and collecting urine via a foley catheter, which is placed in your bladder. Some of the other procedures involved in this study include physical exams, blood work, urine studies, hearing test, and medication administration.

Institution
MUSC
Recruitment Contact
Natalie Drain
843-876-5037
drain@musc.edu

Prospective ctDNA Monitoring in Exceptional Responders to Immunotherapy: A Pilot Study

Date Added
August 8th, 2022
PRO Number
Pro00117604
Researcher
John Kaczmar

List of Studies


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

This study is for subjects that have been diagnosed with advanced cancer. The purpose of this study is to find subjects with advanced cancer that had an exceptional disease response (improvement) while being treated with standard immunotherapy agents. This study will monitor their progression through a series of blood draws. Subjects will either continue immunotherapy or have completed immunotherapy. Participation in the study will take about 6 visits over a period of about 2 years. During this time the study team will follow your care by clinic visit, phone contact and/or medical record review every three months to collect information on the status of your cancer. This is not a treatment study.

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

Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients with Post-ProstaTEctomy Biochemical Recurrence (INDICATE)

Date Added
August 5th, 2022
PRO Number
Pro00122143
Researcher
Harriet Eldredge-Hindy

List of Studies

Keywords
Cancer/Genitourinary, Prostate
Summary

This study is for men with prostate cancer that has come back after surgery. This study is being done to see if PET/CT scans help provide more tailored treatment recommendations and outcomes for men who have prostate cancer after radical prostatectomy (RP) and will adding focal, metastasis directed radiation treatment (e.g.., stereotactic radiation) and/or additional systemic therapy (e.g., apalutamide) to standard of care treatment help to delay progression of prostate cancer in men who have already had an RP and now have recurrence?

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



-- OR --