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.
Study Type
OBSERVATIONAL
Enrollment
650
ADXBLADDER is a non-invasive, qualitative ELISA utilising a combination of two monoclonal antibodies for the detection of MCM5 in urine sediment. It is intended to aid in the monitoring of bladder cancer recurrence in non-muscle-invasive bladder cancer patients. Participants will be asked to provide a full void urine specimen, which will be centrifuged before the urine sediment is lysed. The lysed sample will then be tested with ADXBLADDER.
The Urology Center of Colorado
Denver, Colorado, United States
RECRUITINGAdvanced Urology Institute
Daytona Beach, Florida, United States
RECRUITINGFirst Urology
Jeffersonville, Indiana, United States
RECRUITINGMichigan Institute of Urology
Troy, Michigan, United States
RECRUITINGNew Jersey Urology
Mount Laurel, New Jersey, United States
RECRUITINGAssociated Medical Professionals of NY
Syracuse, New York, United States
RECRUITINGClinical Research Solutions
Cleveland, Ohio, United States
RECRUITINGMidLantic Urology
Philadelphia, Pennsylvania, United States
RECRUITINGCarolina Urologic Research Center
Myrtle Beach, South Carolina, United States
RECRUITINGUrology San Antonio
San Antonio, Texas, United States
RECRUITING...and 3 more locations
Sensitivity, specificity and negative predictive value (NPV) of ADXBLADDDER will be calculated to establish the diagnostic accuracy for the detection of bladder cancer recurrence.
The ADXBLADDER MCM5 results will be compared with the definitive diagnosis obtained by gold standard cystoscopy and pathological assessment of suspicious lesion(s) (where clinically indicated).
Time frame: Urine samples will be collected from participants immediately prior to cystoscopy and analysed for MCM5 within 6 months. Overall performance characteristics of ADXBLADDER will be established following study completion.
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