OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy

Date Added
February 5th, 2024
PRO Number
Pro00133826
Researcher
Frank Brescia

List of Studies


Keywords
Cancer, Cancer/Breast, Women's Health
Summary

This study for subjects that have been diagnosed with triple negative breast cancer (TNBC) and have recently completed preoperative chemotherapy in combination with pembrolizumab, followed by breast surgery. The subjects are expected to be in this study for up to 60 months.

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

Examining Sex and Gender Differences in Patterns of Cannabis Use Motives and Consequences in a Community Sample of Adults Who Use Cannabis

Date Added
February 2nd, 2024
PRO Number
Pro00134281
Researcher
Kathryn Gex

List of Studies

Keywords
Aging, Mental Health, Substance Use, Women's Health
Summary

The goal of this study is to evaluate sex and gender differences across adulthood (18+) in reasons for using cannabis and the perceived severity of consequences associated with cannabis use. We are also interested in understanding how these reasons for cannabis use and perceived severity of consequences are related to other mental and physical health factors. Interested individuals will first complete a brief screening survey. Based on the results of this screening survey, eligible participants will immediately be invited to complete the survey remotely online via a secure web-link. Participants can expect to complete the survey in 30-45 minutes and will be reimbursed $30 via electronic gift card (e.g., Amazon).

Institution
MUSC
Recruitment Contact
Kathryn Gex
843-792-4904
soltisk@musc.edu

A Randomized Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec followed by Platinum-doublet Chemotherapy and Bevacizumab Compared with Platinum-doublet Chemotherapy and Bevacizumab in Women with Platinum-Resistant/Refractory Ovarian Cancer (OnPrime/GOG-3076 Study)

Date Added
January 4th, 2024
PRO Number
Pro00132648
Researcher
Whitney Graybill

List of Studies


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

They study is for patients that have have been diagnosed with platinum-resistant or platinum-refractory ovarian cancer (PRROC) which includes fallopian tube cancer and peritoneal carcinomatosis (a form of cancer that affects the thin membrane that surrounds your abdominal organs). The investigational drug used in this study is Olvi-Vec. The main purpose of the study is to determine how women diagnosed with PRROC will best respond to receiving Olvi-Vec followed by platinum-doublet chemotherapy (platinum-based chemotherapy such as carboplatin or cisplatin are given with a non-platinum based chemotherapy, including gemcitabine, paclitaxel, docetaxel, nab-paclitaxel, or pegylated liposomal doxorubicin [PLD]) along with bevacizumab, known as the Experimental Arm. Participants can expect to be in this study for up to 36 months.

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

A Phase 2, Randomized Study to Evaluate the Safety, Efficacy and Optimal dose of ABBV-400 in Combination with Fluorouracil (5-FU), Folinic Acid and Bevacizumab in Previously Treated Subjects with Unresectable Metastatic Colorectal Cancer (mCRC)

Date Added
December 13th, 2023
PRO Number
Pro00133837
Researcher
Albert Lockhart

List of Studies

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

The purpose of this study is to evaluate investigational treatments (study drug) for unresectable metastatic colorectal cancer to determine if any of these study treatments improve overall survival as compared to standard treatments. The goal is to determine the optimal dose level, safety, and tolerability for the study drug ABBV-400 in combination with fluorouracil, folinic acid, and bevacizumab. The study consists of two stages, Stage 1 - Safety Lead-In Dose Escalation and Stage 2- Dose Optimization. ABBV-400 is not FDA approved. Bevacizumab is FDA approved by the U.S. Food and Drug Administration (FDA) to treat various cancers but may not be approved for your type of cancer. Treatment for this study may be up to 3 years. The procedures include blood and urine samples, questionnaires, infusions, and CT scans. Risks include diarrhea, nausea, vomiting, fatigue, and numbness, tingling, or weakness in arms and legs. You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.

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

Listening to Women and Pregnant and Postpartum People: Qualitative Research with American Indian and Hispanic Women

Date Added
December 1st, 2023
PRO Number
Pro00133257
Researcher
Constance Guille

List of Studies


Keywords
Mental Health, Minorities, Pregnancy, Women's Health
Summary

The purpose of this research study is to gather feedback via focus groups/individual interviews and surveys from American Indian and Hispanic pregnant and postpartum people about 1) mental health and substance use concerns and 2) a text message based mental health and substance use disorder screening, referral and treatment program for pregnant and postpartum people called Listening to Women & Pregnant and Postpartum People (LTWP). By gaining the feedback of American Indian and Hispanic people we hope to improve accessibility and efficacy of this program for these populations. Participation involves one individual interview or focus group (a small group discussion) and surveys.

Institution
MUSC
Recruitment Contact
Tychia Brown
843-872-2439
broty@musc.edu

Equity in Modifying Plaque Of WomEn with UndeRtreated Calcified Coronary Artery Disease (EMPOWER CAD)

Date Added
December 1st, 2023
PRO Number
Pro00132788
Researcher
Anbukarasi Maran

List of Studies


Keywords
Cardiovascular, Women's Health
Summary

This observational study is enrolling women only who are undergoing a heart catheterization with planned percutaneous coronary intervention (PCI) using the Shockwave . A heart catheterization is a procedure in which a long thin tube called a catheter is directed through an artery to your heart, to look for blockages in the heart arteries. If there is a blockage that needs opening, a PCI can be performed to open the blockage. This study involves collecting data only from women participants who undergo a heart catheterization and PCI using the Shockwave IVL System. IVL stands for intravascular lithotripsy. The Shockwave IVL System is approved for use and commercial sale by the Food and Drug Administration. (FDA). Participation in this study will take about 3 years. Participants will be seen before the procedure, during the procedure, before hospital discharge following the procedure, and then seen in clinic or contacted by phone at 30 days, 1,2 and 3 years. This study will collect data from each of these visits including demographic data, medical history and medications, lab results, ECG results, procedure details, and any complications if applicable.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

Multicenter, open-label, phase 2 study of carboplatin plus mirvetuximab soravtansine followed by mirvetuximab soravtansine continuation in folate receptor-alpha positive, recurrent platinum-sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers following 1 prior line of platinum-based chemotherapy

Date Added
November 14th, 2023
PRO Number
Pro00130452
Researcher
Whitney Graybill

List of Studies


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

This study is for female subjects that have a very specific type of recurrent ovarian, peritoneal, or fallopian tube cancer. These patients must have completed 1 round of chemotherapy for their cancer type. The study is testing an "investigational" (not yet FDA approved) drug called MIRV (Mirvetuximab Soravtansine). The primary purpose of this study is to determine the effectiveness and safety of the study drug to determine what effects, if any, it has on subjects. Subjects may remain in the study for up to 2 years.

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

Leveraging Technology to Reduce Disparities and Improve Early Detection of and Timely Care for Postpartum Complications

Date Added
November 7th, 2023
PRO Number
Pro00130902
Researcher
Constance Guille

List of Studies


Keywords
Mental Health, Minorities, Obstetrics and Gynecology, Post Partum Depression, Pregnancy, Psychiatry, Women's Health
Summary

The purpose of the study is to learn if a program for newborn mom's can improve detection of complications after delivery and help women get medical care quickly and easily. Participants will be asked to complete a survey at the time of enrollment and at 4 additional times. All surveys can be completed via cell-phone or email. All women will be followed for 1-year after delivery. Women that enroll will be assigned to one of two groups: usual in person care OR usual in-person care PLUS a text message-based program that will ask about sign and symptoms of complications that may occur after delivery. If there is a concern, a care coordinator will call on the phone to discuss options and help refer to care if needed. Participants will be paid for their time in completing surveys.

Institution
MUSC
Recruitment Contact
Katie Tremont
843-792-5958
tremontk@musc.edu

A Phase III, Single-Arm Study to Evaluate the Efficacy and Safety of ONCOFID-P-B (paclitaxel-hyaluronic acid conjugate) Administered Intravesically to Patients with BCG-unresponsive Carcinoma in Situ of the Bladder with or without Ta-T1 Papillary Disease

Date Added
October 24th, 2023
PRO Number
Pro00128893
Researcher
Stephen Savage

List of Studies


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

The study is for patients that have been diagnosed with carcinoma in situ of the bladder (localized bladder cancer, also called "non-muscle invasive bladder cancer") with or without Ta-T1 papillary disease (Ta means that the cancer is only in the innermost layer of the bladder lining, T1 means that the cancer has started to grow into the connective tissue beneath the bladder lining). The investigational drug used in this study is ONCOFID-P-B. The main purpose of this study is to understand if the study medicine ONCOFID-P-B is effective and safe in treating patients with carcinoma in situ of the bladder who have not received benefit from the standard BCG treatment and are not candidates for radical cystectomy. Participants can expect to be in this study for up to 4 years and will include a screening period of up to 4 weeks followed by up to 33 study visits to the study site.

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

A Phase 1 Multicenter Dose Escalation and Dose Expansion Study of Antibody-Drug Conjugate MYTX-011 in Subjects with Non-Small Cell Lung Cancer

Date Added
September 12th, 2023
PRO Number
Pro00128530
Researcher
Mariam Alexander

List of Studies

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

The purpose of this research is to determine the safety and tolerability, the best dose for future development, as well as antitumor activity of a new antibody drug conjugate (ADC) called MYTX-011. MYTX-011 is a new drug, being studied in humans for the first time for treatment of advanced non-small cell lung cancer. The study team is investigating this drug to help treat lung cancers that are resistant to standard medications. This drug targets a protein called cMET on the cancer cell. MYTX-011 will attach to the cMET and release chemotherapy into the cancer cell.

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



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