Clinical Trial

Evaluating Bladder CARE™, a New Non-Invasive Urine Test, for Bladder Cancer Detection in Inconclusive Cases

Active, Not Recruiting
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Summary
The goal of this observational study is to learn about the performance of the Bladder CARE™ Assay in patients suspected of having bladder cancer with atypical cytology or equivocal cystoscopy results. The main question it aims to answer is: • Does the Bladder CARE™ Assay detect bladder cancer in patients who have inconclusive cytology or cystoscopy results? Participants will provide one voided urine specimen on the day of, and prior to, the routine, scheduled standard of care initial or repeat cystoscopy procedure. A medical records review will occur at two follow-up timepoints, (6 months and 12 months after the urine specimen collection), to document oncology-urinary-related clinical outcomes.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-03-05; most recent amendment 2026-01-02.
Status change: Recruiting → Active, Not Recruiting 2026-01-02
Status change: Not Yet Recruiting → Recruiting 2025-04-11
Trial Details
NCT Number NCT06870253
Lead Sponsor Pangea Laboratory LLC
Conditions Bladder Cancer, Urothelial Carcinoma Bladder
Enrollment 80 participants
Start Date 2025-06-03
Primary Completion 2027-03 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-01-06