Using urine tumor DNA/RNA to guide second TURBT in high-risk non-muscle-invasive bladder cancer

Truce-LB00: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: An Open-Label, Observational, Single-Center Clinical Study

This test tries to see if a urine liquid biopsy measuring tumor DNA and RNA can identify which people with high-risk NMIBC need a second TURBT after initial tumor removal.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tianjin Medical University Second Hospital (Academic / other)
• Locations: 2 sites (Tianjin and 1 other locations)
• Trial ID: NCT07130578 on ClinicalTrials.gov

What this trial studies

This observational study collects urine 2–6 weeks after the initial TURBT and before the planned second TURBT (re-TURBT) to measure urine tumor DNA (utDNA) and RNA (utRNA). Molecular results will be compared with pathology from re-TURBT and any residual tumor to determine how well the urine markers predict leftover disease. The goal is to determine whether utDNA/utRNA can help select patients who truly need re-TURBT and spare others from unnecessary repeat surgery. Eligible participants include adults with high‑risk NMIBC (for example T1 disease, absent detrusor muscle in the initial specimen, or suspected incomplete resection) who can provide the required urine and tissue samples.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed high‑risk non‑muscle‑invasive bladder cancer—particularly T1 tumors, absent detrusor muscle in the initial specimen, or suspected incomplete initial TURBT—who can provide a 50 mL urine sample 2–6 weeks after TURBT and tumor tissue for analysis.

Not a fit: Patients with muscle‑invasive or metastatic disease, low‑risk Ta tumors without CIS, or those unable to provide the required urine or tissue samples are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, urine-based testing could reduce unnecessary re-TURBT procedures, lower surgical risk and costs, and focus interventions on patients with residual disease.

How similar studies have performed: Prior research shows urinary tumor DNA/RNA can detect urothelial carcinoma with high sensitivity and specificity, but applying these markers to decide on re‑TURBT is relatively novel and not yet proven in routine care.

Eligibility criteria

Inclusion Criteria:

Participants must meet all of the following criteria to be eligible for the study:

1. Male or female, aged 18 years or older.
2. Histologically confirmed non-muscle-invasive bladder tumor, with no evidence of muscle-invasive bladder cancer or metastatic disease.
3. Histologically confirmed urothelial carcinoma of the bladder or bladder tumor with urothelial carcinoma as the predominant component (\>50%).
4. At least one of the following conditions:

   1. Incomplete initial transurethral resection of bladder tumor (TURBT) or suspected incomplete resection.
   2. Absence of detrusor muscle in the initial TURBT pathological specimen (except for low-grade Ta stage tumors or carcinoma in situ \[CIS\]).
   3. T1 stage tumor.
5. Willingness to provide a 50 mL urine sample between 2-6 weeks after the initial TURBT and prior to re-TURBT.
6. Willingness to provide tumor tissue samples for pathological examination.
7. Willingness to undergo genetic testing required for the trial.
8. Voluntarily agrees to participate in the study, has signed informed consent, demonstrates good compliance, and is willing to complete study follow-up.

Exclusion Criteria:

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

Where this trial is running

Tianjin and 1 other locations

• General Hospital of Tianjin Medical University — Tianjin, China (Recruiting)
• The second hospital of Tianjin Medical University — Tianjin, China (Recruiting)

Study contacts

• Study coordinator: Hailong Hu, MD

Conditions Bladder Cancer; Liquid Biopsy; NMIBC; re-TURBT