Using urine tumor DNA to guide whether to have a second bladder tumor resection

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)

This study will test whether a urine tumor DNA (utDNA) test can help decide if adults with T1 or uncertain non‑muscle‑invasive bladder cancer need a second transurethral resection (re‑TURBT).

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 196 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tianjin Medical University Second Hospital (other)
• Locations: 6 sites (Nanchang, Anhui and 5 other locations)
• Trial ID: NCT07187635 on ClinicalTrials.gov

What this trial studies

Adults with non‑muscle‑invasive urothelial bladder cancer who had an initial TURBT and meet criteria such as T1 stage, suspected incomplete resection, or absence of detrusor muscle will provide a 50 mL urine sample 2–6 weeks after the first surgery. The urine will be analyzed for tumor DNA (utDNA) and those results will be compared with findings from the planned second transurethral resection and pathological examination of tumor tissue. The trial will determine whether positive or negative utDNA reliably predicts residual tumor and therefore could inform the need for re‑TURBT. The protocol includes collection of tumor tissue and genetic testing and is conducted at multiple hospitals in China.

Who should consider this trial

Good fit: Adults (≥18 years) with histologically confirmed non‑muscle‑invasive urothelial bladder cancer who had an initial TURBT and meet criteria for re‑TURBT (T1 stage, suspected incomplete resection, or absent detrusor muscle) and who can provide urine and tumor tissue samples and undergo required genetic testing.

Not a fit: Patients with muscle‑invasive or metastatic disease, those with low‑grade Ta tumors where re‑TURBT is not indicated, or people unwilling or unable to provide samples or attend the participating hospitals are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the test could spare some patients from an unnecessary second surgery and its anesthesia risks, recovery time, and costs.

How similar studies have performed: Prior studies show utDNA can detect bladder cancer with high sensitivity and may correlate with residual disease, but using utDNA to replace routine re‑TURBT is not yet proven.

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.

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

Nanchang, Anhui and 5 other locations

• Nanchang Second People's Hospital — Nanchang, Anhui, China (RECRUITING)
• Sun Yat-sen Memorial Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)
• Xingtai People's Hospital — Xingtai, Hebei, China (RECRUITING)
• The Second Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (RECRUITING)
• The second hospital of Tianjin Medical University — Tianjin, China (RECRUITING)
• General Hospital of Tianjin Medical University — Tianjin, China (RECRUITING)

Study contacts

• Study coordinator: Hailong Hu, MD

Conditions: Bladder Cancer, Liquid Biopsy, Repeat Transurethral Resection of Bladder Tumor, bladder cancer, liquid biopsy, second transurethral resection of bladder tumor