Actively Recruiting
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
Led by Tianjin Medical University Second Hospital · Updated on 2026-03-03
60
Participants Needed
2
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Histologically confirmed non-muscle-invasive bladder tumor with no muscle-invasive or metastatic disease
- Bladder tumor is urothelial carcinoma or predominantly (>50%) urothelial carcinoma
- At least one of the following: incomplete or suspected incomplete initial TURBT; absence of detrusor muscle in initial TURBT sample (except low-grade Ta or carcinoma in situ); or T1 stage tumor
- Willing to provide a 50 mL urine sample between 2-6 weeks after initial TURBT and before re-TURBT
- Willing to provide tumor tissue samples for pathology
- Willing to undergo genetic testing required for the study
- Voluntarily agrees to participate, has signed informed consent, demonstrates good compliance, and willing to complete follow-up
You will not qualify if you...
- Contraindications to transurethral resection of bladder tumor (TURBT)
- Concurrent cancer in the upper urinary tract (ureter or renal pelvis)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
General Hospital of Tianjin Medical University
Tianjin, China, 300000
Actively Recruiting
2
The second hospital of Tianjin Medical University
Tianjin, China
Actively Recruiting
Research Team
H
Hailong Hu, MD
CONTACT
Y
Yunkai Qie, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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