RecruitingNCT07130578

The Guiding Value of Liquid Biopsy Based on Urinary Tumor DNA/RNA in the Second Transurethral Resection of High-risk Non-muscle Invasive Bladder Cancer

Truce-LB00:The Guiding Value of Liquid Biopsy Based on Urinary Tumor DNA/RNA in the Second Transurethral Resection of High-risk Non-muscle Invasive Bladder Cancer: An Open-Label, Observational, Single-Center Clinical Study


Sponsor

Tianjin Medical University Second Hospital

Enrollment

60 participants

Start Date

Sep 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

High-risk non-muscle-invasive bladder cancer (NMIBC) carries a substantial risk of residual disease after initial transurethral resection of bladder tumor (TURBT). Current guidelines recommend a second TURBT (re-TURBT) within 2-6 weeks for patients with stage T1 disease to remove residual tumor, confirm staging, and obtain additional pathological information. However, the actual survival benefit of routine re-TURBT for all high-risk patients remains debated, and the procedure may pose surgical risks, increase healthcare costs, and impact patient quality of life. Urine tumor DNA (utDNA) and urine tumor RNA (utRNA) are molecular biomarkers detectable through non-invasive "liquid biopsy" methods. In urothelial carcinoma, tumor-derived nucleic acids can be shed into urine, where they can be detected with high sensitivity and specificity. These biomarkers may help identify patients most likely to harbor residual disease after initial TURBT, and thus most likely to benefit from re-TURBT. This prospective, open-label, observational, single-center study aims to evaluate the clinical value of utDNA/utRNA testing in guiding re-TURBT for patients with high-risk NMIBC. The study will assess whether molecular urine testing can improve patient selection for re-TURBT, potentially reducing unnecessary procedures while maintaining oncological safety.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether analyzing DNA and RNA from a urine sample — a non-invasive "liquid biopsy" — can help doctors decide whether a second surgical procedure is needed for patients with high-risk non-muscle-invasive bladder cancer. **You may be eligible if...** - You are 18 or older - You have confirmed non-muscle-invasive bladder cancer (urothelial type) - You need a second surgical procedure because: the first surgery may have been incomplete, muscle tissue was absent from the biopsy sample, or your tumor is stage T1 - You are willing to provide a urine sample **You may NOT be eligible if...** - You have a contraindication to bladder tumor surgery - You also have cancer in the upper urinary tract (ureter or kidney pelvis) 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_TESTurine tumor DNA/RNA testing

The test analyzes DNA and RNA fragments shed by urothelial carcinoma cells into urine, detecting tumor-specific genetic and epigenetic alterations.


Locations(2)

General Hospital of Tianjin Medical University

Tianjin, China

The second hospital of Tianjin Medical University

Tianjin, China

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NCT07130578


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