RecruitingNot ApplicableNCT07187635

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

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)


Sponsor

Tianjin Medical University Second Hospital

Enrollment

196 participants

Start Date

Sep 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Non-muscle-invasive bladder cancer (NMIBC) accounts for approximately 75% of newly diagnosed bladder cancers and is characterized by a high risk of recurrence and progression. Current guidelines recommend that patients with stage T1 NMIBC undergo a second transurethral resection of bladder tumor (re-TURBT) within 2-6 weeks after the initial surgery to remove residual tumor, confirm staging, and obtain additional pathological information. However, the benefits of routine re-TURBT for all high-risk patients remain controversial, as many patients may not have residual disease, while the procedure carries surgical and anesthetic risks, physical and psychological burden, and additional healthcare costs. Urine tumor DNA (utDNA) refers to DNA fragments shed by tumor cells into urine. It can be detected using molecular assays with high sensitivity and specificity, offering a non-invasive method for bladder cancer diagnosis and surveillance. Previous studies have shown that positive utDNA results after initial TURBT may be associated with residual disease and higher recurrence risk. This multicenter, randomized controlled trial aims to evaluate whether utDNA testing can accurately identify NMIBC patients who are most likely to benefit from re-TURBT, thereby guiding the decision to perform the procedure. The goal is to optimize patient selection for re-TURBT, reduce unnecessary surgeries, and improve patient quality of life while maintaining oncologic safety.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a urine DNA test (detecting tumor DNA shed by cancer cells) can accurately predict whether cancer remains after an initial surgery, and help guide decisions about whether a second surgery (re-TURBT) is truly necessary in people with non-muscle-invasive bladder cancer. **You may be eligible if...** - You are 18 or older with confirmed non-muscle-invasive bladder cancer (urothelial carcinoma) - Your initial surgery may have been incomplete, had no muscle tissue in the specimen, or your tumor was Stage T1 - You are willing to provide a urine sample before a second surgical procedure **You may NOT be eligible if...** - You have any reason that makes bladder surgery unsafe - You have simultaneous cancer in the upper urinary tract (kidney or ureter) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESecond Transurethral Resection of Bladder Tumor (re-TURBT)

Participants with NMIBC who have undergone initial TURBT will not receive utDNA testing and will undergo a second transurethral resection of bladder tumor (re-TURBT) within 2-6 weeks after the initial surgery, in accordance with current clinical guidelines.

DIAGNOSTIC_TESTutDNA Testing (Urine Tumor DNA Detection)

Participants with NMIBC who have undergone initial TURBT will receive urine tumor DNA (utDNA) testing. If utDNA is positive, the patient will undergo a second transurethral resection of bladder tumor (re-TURBT) within 2-6 weeks after the initial surgery. If utDNA is negative, re-TURBT will be omitted and patients will proceed to guideline-based adjuvant therapy or surveillance.


Locations(2)

The second hospital of Tianjin Medical University

Tianjin, China

General Hospital of Tianjin Medical University

Tianjin, China

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NCT07187635


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