The Guiding Value of Urinary Tumor DNA Testing in Cystoscopy for High-Risk/Very High-Risk Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized Controlled, Multicenter Clinical Study (Truce-LB02)

What this Trial Is About

Researchers are evaluating a new approach to monitoring high-risk or very high-risk non-muscle-invasive bladder cancer (NMIBC). This type of bladder cancer is often treated with surgery to remove tumors, followed by bladder medications to reduce recurrence. However, cancer can still return or progress, so patients need regular check-ups that usually involve cystoscopy, an invasive camera exam of the bladder. This study is testing whether a urine tumor DNA (utDNA) test, a non-invasive liquid biopsy detecting cancer DNA in urine, can help guide the timing of cystoscopy and reduce unnecessary procedures while safely monitoring for recurrence. Participants are randomly assigned to one of two groups. One group undergoes utDNA testing and urine cytology every three months, with cystoscopy once per year. If either test is positive, an additional cystoscopy is done, and if certain test results are positive while cystoscopy is negative, a computed tomography urography (CTU) scan is performed to check the upper urinary tract. The comparison group follows the standard approach of cystoscopy and urine cytology every three months, with CTU if urine cytology is positive but cystoscopy is negative. Participants will have regular urine tests, cystoscopy exams, and imaging as needed over 24 months. The study measures cancer recurrence-free survival, number of cystoscopies performed, progression-free survival, and accuracy of utDNA testing in detecting cancer return. Patient quality of life is also assessed through questionnaires. This detailed monitoring aims to find a more comfortable, precise, and efficient way to follow up with bladder cancer patients while ensuring safety.

Guiding Value of Urinary Tumor DNA Testing in Cystoscopy for High-Risk/Very High-Risk Non-Muscle-Invasive Bladder Cancer