NCT07514897

Detecting CREPT in Urine for Bladder Cancer Diagnosis and Monitoring

Detection of CREPT Expression in Exfoliated Urothelial Cells for Early Diagnosis and Recurrence Monitoring of Bladder Cancer

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study will, for the first time, establish a non-invasive diagnostic model for bladder cancer based on CREPT expression levels in exfoliated urothelial cells using a multicenter cohort, and validate its value in the non-invasive diagnosis and recurrence monitoring of bladder cancer. Its high sensitivity is expected to overcome the technical limitations of existing biomarkers and provide an innovative solution for establishing an integrated precision diagnosis and treatment system encompassing "screening, diagnosis, and monitoring."

Detailed description

The main research content of this project will be carried out from the following aspects: (1) Establish an exploratory cohort comprising patients with bladder cancer, patients with benign urological diseases, and healthy individuals. The exploratory cohort will be randomly divided into a training cohort and an internal validation cohort in a 2:1 ratio. Using the training cohort, a non-invasive detection method for bladder cancer based on CREPT expression in exfoliated urothelial cells will be developed, and a non-invasive diagnostic model for bladder cancer based on CREPT expression in exfoliated urothelial cells will be constructed. The diagnostic performance of the model will then be validated using the internal validation cohort; (2) Establish an external validation cohort including patients with bladder cancer, benign urological diseases, and healthy individuals to evaluate the clinical diagnostic performance of the model; (3) Enroll patients with bladder cancer undergoing follow-up cystoscopy after Transurethral Resection of Bladder Tumor (TURBT) and patients requiring repeat TURBT to establish a recurrence monitoring cohort, and evaluate the performance of this diagnostic model in predicting bladder cancer recurrence.

Conditions

• Bladder Cancer

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: China