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

Study Overview
=================
Brief 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.

Detailed 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.

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

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Device: Bladder EpiCheck Urine Test
* Procedure: Cystoscopy and pathology


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bladder EpiCheck Urine Test<br>Bladder EpiCheck Urine Test | Device: Bladder EpiCheck Urine Test<br>* 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<br>|
| Active Comparator: Gold Standard<br>Cystoscopy and pathology | Procedure: Cystoscopy and pathology<br>* Routine cystoscopy for bladder cancer recurrence and pathology confirmation for patients with positive cystoscopy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity of Bladder EpiCheck Urine Test Kit (the proportion of negatives that are correctly identified as such by the gold standard) |  | Day 1 | 
| Sensitivity of Bladder EpiCheck Urine Test Kit (The proportion of positives that are correctly identified as such by the gold standard) |  | Day 1 |