NCT06870253

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

Prospective Evaluation of Bladder CARE™ Assay Utility for the Diagnosis of Bladder Cancer in Patients With Atypical Cytology or Equivocal Cystoscopy

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Pangea Laboratory LLC · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer
• Urothelial Carcinoma Bladder

Timeline

• Start date: 2025-06-03
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2025-03-11
• Last updated: 2026-01-06

Locations

1 site across 1 country: United States