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

Sponsor
Tianjin Medical University Second Hospital
Study ID
NCT07187635
Status
Recruiting
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Conditions

  • Bladder Cancer
  • Liquid Biopsy
  • Repeat Transurethral Resection of Bladder Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Second Transurethral Resection of Bladder Tumor (re-TURBT) — PROCEDURE
    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.
  • utDNA Testing (Urine Tumor DNA Detection) — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

First listed
Sep 23, 2025
Start date
Sep 28, 2025
Status verified
May 2026
Primary completion
Oct 1, 2027
Completion
Nov 1, 2027

Study Design

Enrollment
196 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard 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, per guideline-based management.
  • Experimental: utDNA-guided management
    Participants with NMIBC who have undergone initial TURBT will receive urine tumor DNA (utDNA) testing. If utDNA positive, they will undergo re-TURBT within 2-6 weeks after the initial surgery. If utDNA negative, re-TURBT will be omitted and patients will continue guideline-based adjuvant therapy/surveillance as per protocol.

Primary Outcome Measure

Recurrence-free survival (RFS) [ Time Frame: Up to 24 months from randomization ]

Central Contacts

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