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

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.

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Key information

Conditions

Bladder Cancer Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Liquid Biopsy Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital of Tianjin Medical University, Tianjin, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
Voluntarily agrees to participate in the study, has signed informed consent, demonstrates good compliance, and is willing to complete study follow-up.

Exclusion criteria

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

Treatment and study plan

urine tumor DNA/RNA testing

Diagnostic Test

The test analyzes DNA and RNA fragments shed by urothelial carcinoma cells into urine, detecting tumor-specific genetic and epigenetic alterations.

Primary outcomes

Concordance analysis of urine tumor DNA/RNA testing results with results of secondary TURBT histopathology

Time frame: Through study completion, an average of 6 months

Through Concordance analysis of urine tumor DNA/RNA testing results with gold standard results of secondary TURBT histopathology, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) are measured.

Study contacts

Contact information is provided by the study sponsor or research team.

Hailong Hu, MD

CONTACT

[email protected]

+8613662096232

Yunkai Qie, MD

CONTACT

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Second Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Aug 19, 2025
Registry last updated: Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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