The Guiding Value of Urinary Tumor DNA Testing in Repeat Transurethral Resection of Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized Controlled, Multi-Center Clinical Study (Truce-LB01)

What this Trial Is About

Non-muscle-invasive bladder cancer (NMIBC) accounts for about 75% of newly diagnosed bladder cancers and carries a high risk of the cancer returning or progressing. Current guidelines recommend a second surgery called repeat transurethral resection of bladder tumor (re-TURBT) within 2-6 weeks after the first surgery to remove any leftover tumor and confirm cancer stage. This trial is investigating whether testing urine for tumor DNA (utDNA) can help identify patients who really need this second surgery, aiming to reduce unnecessary procedures and improve quality of life while ensuring cancer safety. Participants with NMIBC who have had initial surgery will either follow the standard approach by having a second surgery within 2-6 weeks, or they will have urine tested for tumor DNA. If the utDNA test is positive, they will have the second surgery; if negative, the surgery will be skipped and they will continue with recommended follow-up treatment and monitoring. This study compares these two approaches to see if utDNA testing can guide treatment decisions better. During the study, participants will provide urine and tumor tissue samples and may undergo genetic testing. Researchers will track cancer recurrence and progression for up to 24 months after randomization, along with pathological results from repeated surgery and patient-reported outcomes. The study involves regular evaluations to monitor health and treatment effects, aiming to find the best way to manage NMIBC while minimizing unnecessary surgeries.

Guiding Value of Urinary Tumor DNA Testing in Repeat Transurethral Resection of Non-Muscle-Invasive Bladder Cancer