Multicenter Study Monitoring Recurrence of Urothelial Carcinoma Using Urine Microscopic Residual Disease Detection

What this Trial Is About

Researchers are conducting a multicenter, prospective observational study to monitor the recurrence of urothelial carcinoma, a type of urinary tract cancer. The study includes four patient groups those with high-risk upper tract urothelial carcinoma UTUC, patients with non-muscle invasive bladder cancer NMIBC, patients with muscle-invasive bladder cancer MIBC undergoing neoadjuvant therapy, and patients who have achieved complete response after trimodality therapy TMT and preserved their bladder. The goal is to evaluate the sensitivity and specificity of a urinary microscopic residual disease MRD score for detecting tumor recurrence or residual disease. Participants provide urine samples for MRD testing at specific times depending on their group before and after treatment cycles, or during regular postoperative reviews every six months up to one year. Imaging assessments are also used to confirm clinical status and disease presence, including evaluations before TMT or neoadjuvant therapy. The study observes patients undergoing standard treatments such as surgery, chemotherapy, and TMT without altering their care. During the study, patients undergo urine sample collection and imaging assessments at set intervals to monitor disease status. The MRD score is the main outcome measure, recorded at baseline and during treatment or follow-up visits. Researchers will analyze how well the MRD score predicts tumor recurrence, residual tumors, or metastases. The study lasts up to one year post-treatment with regular reviews and urinary testing, providing ongoing monitoring for participants while documenting their clinical outcomes.

A Multicenter Prospective Cohort Study on Monitoring Recurrence of Urothelial Carcinoma Based on Detection of Urinary Microscopic Residual Disease (MRD)