The Guiding Value of Urinary Tumor DNA Testing in Repeat Transurethral Resection of Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized Controlled, Multi-Center Clinical Study (Truce-LB01)


Condition: Bladder Cancer, Liquid Biopsy, Repeat Transurethral Resection of Bladder Tumor

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07187635

Sponsor: Tianjin Medical University Second Hospital

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  1. Participants must meet all of the following criteria to be eligible for the study:
  2. Male or female, aged 18 years or older.
  3. Histologically confirmed non-muscle-invasive bladder tumor, with no evidence of muscle-invasive bladder cancer or metastatic disease.
  4. Histologically confirmed urothelial carcinoma of the bladder or bladder tumor with urothelial carcinoma as the predominant component (>50%).
  5. At least one of the following conditions:
  6. Incomplete initial transurethral resection of bladder tumor (TURBT) or suspected incomplete resection.
  7. Absence of detrusor muscle in the initial TURBT pathological specimen (except for low-grade Ta stage tumors or carcinoma in situ [CIS]).
  8. T1 stage tumor.
  9. Willingness to provide a 50 mL urine sample between 2-6 weeks after the initial TURBT and prior to re-TURBT.
  10. Willingness to provide tumor tissue samples for pathological examination.
  11. Willingness to undergo genetic testing required for the trial.

Exclusion Criteria:

  1. Contraindications to transurethral resection of bladder tumor (TURBT).
  2. Concurrent malignancy of the upper urinary tract (ureter or renal pelvis).

View trial on ClinicalTrials.gov