RecruitingNot ApplicableNCT07180212

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

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)


Sponsor

Tianjin Medical University Second Hospital

Enrollment

360 participants

Start Date

Sep 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Non-muscle-invasive bladder cancer (NMIBC) is usually treated with surgery to remove the tumor (transurethral resection of bladder tumor, or TURBT), often followed by bladder-instilled medications to reduce the chance of the cancer coming back. Even with this treatment, high-grade NMIBC can return or progress, so patients need regular check-ups, usually with cystoscopy (a camera examination of the bladder) and urine cytology. Cystoscopy is effective but invasive, can cause discomfort, and carries risks such as infection and bleeding. This makes follow-up costly and sometimes burdensome for patients. This study is testing whether a urine tumor DNA (utDNA) test - a type of "liquid biopsy" that detects cancer-related DNA changes in urine - can help guide the timing of cystoscopy for people with high-risk or very high-risk NMIBC. utDNA testing is non-invasive and has shown high accuracy in detecting bladder cancer, sometimes spotting signs of recurrence earlier than standard methods. By combining utDNA testing with cystoscopy, we hope to safely reduce the number of unnecessary cystoscopies without missing cancer recurrences. The study will evaluate whether this approach can make bladder cancer follow-up more comfortable, more precise, and more efficient.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether testing tumor DNA in the urine can help guide the use of cystoscopy (a camera examination of the bladder) in people with high-risk bladder cancer that has not yet invaded the muscle. It aims to determine if urine DNA testing could reduce the need for frequent invasive check-up procedures. **You may be eligible if...** - You are 18 or older - You have been diagnosed with high-risk or very high-risk non-muscle-invasive bladder cancer within the past 2 years - You have had a complete tumor removal procedure (TURBT) with no remaining visible tumor - You have adequate kidney function **You may NOT be eligible if...** - Your bladder cancer has already invaded the muscle layer - You have evidence of cancer spread beyond the bladder - You have severe kidney disease 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

DIAGNOSTIC_TESTutDNA testing + Urine Cytology

Participants undergo urine tumor DNA (utDNA) testing and urine cytology every 3 months, and cystoscopy once per year. If either utDNA or urine cytology is positive, an additional cystoscopy will be performed. If urine cytology is positive but cystoscopy is negative, or if two consecutive utDNA tests are positive while cystoscopy remains negative, participants will undergo computed tomography urography (CTU) to evaluate the upper urinary tract.

DIAGNOSTIC_TESTCystoscopy + Urine Cytology

Participants undergo cystoscopy and urine cytology every 3 months as per standard high-risk NMIBC surveillance. If urine cytology is positive but cystoscopy is negative, participants will undergo computed tomography urography (CTU) to evaluate the upper urinary tract.


Locations(2)

Sun Yat-Sen Memorial Hosipital of Sun Yat-Sen University

Guangzhou, China

The second hospital of Tianjin Medical University

Tianjin, China

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NCT07180212


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