A Randomized Open-Label Phase 2/3 Study of BT8009 as Monotherapy or in Combination in Participants with Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

Date Added
August 30th, 2024
PRO Number
Pro00136410
Researcher
Theodore Gourdin

List of Studies


Keywords
Bladder, Cancer, Cancer/Genitourinary
Summary

This research study primarily aims to determine if BT8009 alone and when given in combination with pembrolizumab works against urothelial cancer for patients who previously received treatment for their locally advanced or metastatic cancer.
This research study also aims to understand the side effects of BT8009 when given alone and in combination with pembrolizumab.
The study drug BT8009 is investigational (i.e., experimental). An investigational drug is one that has not been approved by the Regulatory Authority to treat a certain condition or illness or a certain type of patient.

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

Replacing Invasive Cystoscopy with Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance

Date Added
February 12th, 2024
PRO Number
Pro00134992
Researcher
Robert Grubb

List of Studies


Keywords
Bladder, Cancer
Summary

The purpose of this research is to determine whether bladder cancer monitoring can be improved by replacing some cystoscopy procedures with investigational urine testing. Specifically, we are examining whether there are any differences in urinary symptoms, discomfort, number of invasive procedures, anxiety, complications, cancer recurrence or cancer progression when some cystoscopy procedures are replaced with urine testing.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
8438760630
jenkijn@musc.edu

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Arm Study to Assess the Safety and Efficacy of a Single Treatment of BOTOX®, Followed by an Optional Open-Label Treatment with BOTOX®, in Female Subjects with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Date Added
January 29th, 2024
PRO Number
Pro00120543
Researcher
Eric Rovner

List of Studies


Keywords
Bladder
Summary

The purpose of this study is to investigate the safety (what side effects the study treatment may have) and effectiveness (how well the study treatment works to relieve symptoms) of BOTOX when injected into the bladder of adult females for the treatment of Interstitial Cystitis/ Bladder Pain Syndrome. Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a chronic and debilitating urological condition characterized by symptoms of bladder pain or discomfort and accompanied by lower urinary tract symptoms such as frequent toilet visits, often also during bedtime. BOTOX might be able to temporarily reduce bladder pain/discomfort and improve your accompanying urinary symptoms. There will be a total of 9 study visits over a period of approximately 28 weeks which includes up to 28 days (4 weeks of screening), a treatment visit, and 24 weeks of follow-up if you receive only one treatment. If you choose to receive a second treatment (which will be BOTOX), you could have a total of up to 13 visits and be in the study for an additional 12 weeks for a total of up to 44 weeks (depending on when you request retreatment) which includes the 28 days (4 weeks of screening). If you are already
receiving treatment for IC-BPS, after you have signed the informed consent, you may have to washout of your medication prior to screening and throughout your study participation. If you have a urinary tract infection [UTI] that requires treatment, an additional 14-day extension is allowed to receive Treatment 2 for total study
participation of up to 46 weeks. You may need to attend additional unscheduled visits for safety or other reasons.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
8438760630
jenkijn@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

Pediatrics Biorepository for Nephrology Clinical Research

Date Added
April 20th, 2023
PRO Number
Pro00124386
Researcher
Katherine Twombley

List of Studies


Keywords
Bladder, Children's Health, Kidney, Urinary
Summary

The goal of this study is to develop a biorepository to store pediatric biospecimens from nephrology cohorts for on-going and future research studies. These studies plan to advance the state of science in the hopes to find more information that potentially leads to developing novel diagnostic approaches and identify therapeutic targets to prevent and/or treat pediatric disease involving the kidneys.

Institution
MUSC
Recruitment Contact
Katherine Twombley
843-792-8904
twombley@musc.edu

A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)

Date Added
April 17th, 2023
PRO Number
Pro00128249
Researcher
Stephen Savage

List of Studies


Keywords
Bladder, Cancer/Genitourinary
Summary

This study is for patients with bladder cancer. The study is being done to see if by using one type of chemotherapy instilled in the bladder, Gemcitabine and Docetaxel, instead of the usual BCG therapy can lower the chance of the patient's bladder cancer from growing or spreading.

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

A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)

Date Added
April 17th, 2023
PRO Number
Pro00128249
Researcher
Stephen Savage

List of Studies


Keywords
Bladder, Cancer/Genitourinary
Summary

This study is for patients with bladder cancer. The study is being done to see if by using one type of chemotherapy instilled in the bladder, Gemcitabine and Docetaxel, instead of the usual BCG therapy can lower the chance of the patient's bladder cancer from growing or spreading.

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

Single Institution Registry of Prostatic Artery Embolization for Lower Urinary Tract Symptoms due to Benign Prostatic Obstruction

Date Added
March 13th, 2020
PRO Number
Pro00097914
Researcher
Stephen Stringfellow

List of Studies

Keywords
Aging, Bladder
Summary

This study will collect prospective data on clinical indications, outcomes, and adverse events related to Prostatic Artery Embolization (PAE) at the Medical University of South Carolina. Patients undergoing surgical treatment for benign prostatic obstruction causing LUTS will also be allowed to enroll in this registry for the purposes of comparison. Patients will be followed at 1, 3, and 12 months post-procedure, for a period of up to 5 years. Patients will remain enrolled in the registry for a period of 5 years.

Institution
MUSC
Recruitment Contact
Andre Uflacker
8438765556
uflackera@musc.edu



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