NCT05864599

External Validation of Uromonitor as a Biomarker for Optimization of NMIBC Management by the CUETO Group

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Pharmalink · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

Independent validation of Uromonitor as a non-invasive biomarker of recurrence of Non Muscle Invasive Bladder Cancer

Detailed description

This study is intended as an independent validation series for previous studies performed in several European centers with less statistical power. We expect to validate the results from a previous study, reaching the sensitivity and specificity data obtained at generation and first external validation papers. The overall goal of this study is to perform a bigger external multicenter validation study to evaluate the sensitivity, specificity, NPV and PPV of Uromonitor for the detection of bladder cancer recurrence in an independent series of patients. The specific objectives of this study protocol are the following: Main endpoint: • To evaluate the clinical sensitivity, specificity, NPV and PPV of Uromonitor in the detection of bladder cancer recurrence in patients previously diagnosed (over the last 3 months to 2 years) of NMIBC, treated or not, by testing a total of 600 patients (EVALUATION-CUETO Study)

Conditions

• Non-muscle-invasive Bladder Cancer

Timeline

• Start date: 2023-06-16
• Primary completion: 2024-05-01
• Completion: 2024-06-01
• First posted: 2023-05-18
• Last updated: 2024-04-03

Locations

1 site across 1 country: Spain