The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma

The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma: A Multicenter, Prospective Blinded Pivotal Study

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.

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.

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