The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma: A Multicenter, Prospective Blinded Pivotal Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bladder Cancer
- Sponsor
- Nucleix Ltd.
- Enrollment
- 680
- Locations
- 11
- Primary Endpoint
- Specificity of Bladder EpiCheck Urine Test Kit (the proportion of negatives that are correctly identified as such by the gold standard)
- Status
- Completed
- Last Updated
- 4 years ago
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.
Investigators
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
Outcomes
Primary Outcomes
Specificity of Bladder EpiCheck Urine Test Kit (the proportion of negatives that are correctly identified as such by the gold standard)
Time Frame: Day 1
Sensitivity of Bladder EpiCheck Urine Test Kit (The proportion of positives that are correctly identified as such by the gold standard)
Time Frame: Day 1