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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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Nov 1, 2025 to Nov 1, 2026 Start date: May 1, 2025 to Sep 1, 2025 · Study sites: 1 to 2 · Completion date: Dec 1, 2025 to May 1, 2027v2 Show 3 more changesShow less
    • Start date: May 1, 2025 to Sep 1, 2025
    • Study sites: 1 to 2
    • Completion date: Dec 1, 2025 to May 1, 2027
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07130578
Lead Sponsor Tianjin Medical University Second Hospital
Conditions Bladder Cancer, Liquid Biopsy
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov