Spots Global Cancer Trial Database for A Performance Evaluation Study of Arquer's MCM5 Elisa Test (ADXBLADDER) to Aid in the Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
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Trial Identification
Brief Title: A Performance Evaluation Study of Arquer's MCM5 Elisa Test (ADXBLADDER) to Aid in the Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
Official Title: A Performance Evaluation Study of Arquer's MCM5 Elisa Test (ADXBLADDER) to Aid in the Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
Study ID: NCT05508568
Conditions
Interventions
Study Description
Brief Summary: The objective of this prospective, multi-centre study is to evaluate the performance of ADXBLADDER, a urine MCM5 ELISA test, as an aid in the detection of bladder cancer recurrence. Patients undergoing cystoscopic surveillance in non-muscle invasive bladder cancer (NMIBC) follow-up will be recruited and asked to provide a urine sample to be tested with ADXBLADDER. To assess the diagnostic accuracy of the test, the MCM5 results will be compared with the gold standard cystoscopy and pathology of resected tissue.
Detailed Description:
Eligibility
Minimum Age: 22 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Urology Center of Colorado, Denver, Colorado, United States
Advanced Urology Institute, Daytona Beach, Florida, United States
First Urology, Jeffersonville, Indiana, United States
Michigan Institute of Urology, Troy, Michigan, United States
New Jersey Urology, Mount Laurel, New Jersey, United States
Associated Medical Professionals of NY, Syracuse, New York, United States
Clinical Research Solutions, Cleveland, Ohio, United States
MidLantic Urology, Philadelphia, Pennsylvania, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Urology San Antonio, San Antonio, Texas, United States
Virginia Urology Center, Richmond, Virginia, United States
Urology of Virginia, Virginia Beach, Virginia, United States
Spokane Urology, Spokane, Washington, United States
Contact Details
Name: Professor Ashish Kamat
Affiliation: The University of Texas MD Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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