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