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

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Site details revised at 8 of 8 sites · Eligibility criteria expanded, about 3 words Show 2 more changesShow less
    • Site details revised at 8 of 8 sites
    • Eligibility criteria expanded, about 3 words
  2. Trial sites expanded: 2 → 8 locationsv5
  3. Start date: Jul 1, 2025 to Sep 20, 2025 Primary endpoints: 1 to 2 · Study sites: 1 to 2 · Primary completion date: Jul 1, 2027 to Oct 1, 2027 · 2 morev4 Show 5 more changesShow less
    • Primary endpoints: 1 to 2
    • Study sites: 1 to 2
    • Primary completion date: Jul 1, 2027 to Oct 1, 2027
    • Completion date: Sep 1, 2027 to Nov 1, 2027
    • Secondary endpoints: 2 to 7

    See this version in full on ClinicalTrials.gov ↗

  4. Secondary endpoints: details revised at 1 of 2 entriesv3
  5. Study title shortened, about 8 wordsv2 See this version in full on ClinicalTrials.gov ↗
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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.
Trial Details
NCT Number NCT07180212
Lead Sponsor Tianjin Medical University Second Hospital
Conditions Bladder Cancer, Liquid Biopsy, Cystoscopy
Enrollment 360 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov