Bladder Cancer Clinical Trial
The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma
Summary
Clinical trial to determine the efficacy (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for recurrence of bladder cancer.
Full Description
The Bladder EpiCheck test is an in vitro diagnostic device for the detection of DNA methylation patterns in urine that are associated with bladder cancer. It is intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy inpatients previously diagnosed with bladder cancer This is a, multicenter, prospective, blinded study to evaluate the efficacy (sensitivity and specificity) of a novel methylation test for the detection of recurrent Urothelial Cell Carcinoma in patients with a history of bladder cancer undergoing surveillance.
Eligibility Criteria
Inclusion Criteria:
Any male or female patient diagnosed with incident or recurrent Urothelial Cell Carcinoma and undergoing surveillance at 3 month intervals.
Has had all urothelial cell carcinoma tumor resected within the past 12 months
Has a plan for cystoscopic surveillance (adjuvant intravesical therapy allowed)
Able to provide legally effective informed consent
Able to produce 45mL of urine
Exclusion Criteria:
Planning to undergo radical cystectomy or chemotherapy-radiation for Urothelial Cell Carcinoma
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There are 11 Locations for this study
Denver Colorado, 80211, United States
Baltimore Maryland, 21237, United States
Troy Michigan, 48084, United States
Woodbury Minnesota, 55125, United States
Garden City New York, 11530, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44195, United States
Nashville Tennessee, 37232, United States
San Antonio Texas, 78229, United States
Seattle Washington, 98195, United States
Toronto Ontario, M5G 1, Canada
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