NCT07130578Recruiting
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
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
Source: ClinicalTrials.gov · Last updated 3 Mar 2026
Brief summary (registry, in English)
High-risk non-muscle-invasive bladder cancer (NMIBC) carries a substantial risk of residual disease after initial transurethral resection of bladder tumor (TURBT). Current guidelines recommend a second TURBT (re-TURBT) within 2-6 weeks for patients with stage T1 disease to remove residual tumor, confirm staging, and obtain additional pathological information. However, the actual survival benefit of routine re-TURBT for all high-risk patients remains debated, and the procedure may pose surgical risks, increase healthcare costs, and impact patient quality of life. Urine tumor DNA (utDNA) and urine tumor RNA (utRNA) are molecular biomarkers detectable through non-invasive "liquid biopsy" methods. In urothelial carcinoma, tumor-derived nucleic acids can be shed into urine, where they can be detected with high sensitivity and specificity. These biomarkers may help identify patients most likely to harbor residual disease after initial TURBT, and thus most likely to benefit from re-TURBT. This prospective, open-label, observational, single-center study aims to evaluate the clinical value of utDNA/utRNA testing in guiding re-TURBT for patients with high-risk NMIBC. The study will assess whether molecular urine testing can improve patient selection for re-TURBT, potentially reducing unnecessary procedures while maintaining oncological safety.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 12 Aug 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- Tianjin Medical University Second Hospital
- Diseases
- Bladder cancer
- NCT number
- NCT07130578
What you commit to
- Study type: Observational
- Planned participants: 60
- From 1 Sept 2025 to the primary completion date, 1 Nov 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to transurethral resection of bladder tumor (TURBT).
- Concurrent malignancy of the upper urinary tract (ureter or renal pelvis).
Who the study is looking for
- 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.
- Voluntarily agrees to participate in the study, has signed informed consent, demonstrates good compliance, and is willing to complete study follow-up.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| General Hospital of Tianjin Medical University Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| The Second Hospital of Tianjin Medical University Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.