Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma A Multicenter, Prospective Blinded Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bladder Cancer
- Sponsor
- Nucleix Ltd.
- Enrollment
- 1050
- Locations
- 6
- Primary Endpoint
- Specificity (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 performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology.
Detailed Description
Clinical trial to determine the performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for reccurrence of bladder cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient diagnosed with incident or recurrent urothelial cell carcinoma and undergoing surveillance monitoring for urothelial cell carcinoma
- •Has all urothelial cell carcinoma tumor resected within the past 12 months
- •Has a plan for cystoscopic surveillance
Exclusion Criteria
- •Planning to undergo radical cystectomy or chemotherapy-radiation for UCC
Outcomes
Primary Outcomes
Specificity (the proportion of negatives that are correctly identified as such by the gold standard)
Time Frame: Day 1
the proportion of negatives that are correctly identified as such by the gold standard
Sensitivity (the proportion of positives that are correctly identified as such by the gold standard)
Time Frame: Day 1
the proportion of positives that are correctly identified as such by the gold standard