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

NCT07130578 | Recruiting

• 1 other identifier: Truce-LB00
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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

Bladder Cancer; Liquid Biopsy

Keywords

Bladder Cancer; Liquid Biopsy; NMIBC; re-TURBT

Outcome Measures

Primary Outcomes (1)

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

  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.

  Through study completion, an average of 6 months

Study Arms (1)

Study group

All enrolled patients will undergo urine tumor DNA (utDNA) and urine tumor RNA (utRNA) testing between 2-6 weeks after the initial transurethral resection of bladder tumor (TURBT) and prior to the second TURBT (re-TURBT). The re-TURBT procedure will include deep resection at the site of the original tumor base, complete resection of tumor margins and any suspicious areas, as well as random bladder biopsies as indicated. The results of utDNA/utRNA testing will be compared with pathological findings from the re-TURBT specimens to evaluate the diagnostic value of molecular urine testing in detecting residual disease.

Diagnostic Test: urine tumor DNA/RNA testing

Interventions

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.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (≥18 years) with histologically confirmed high-risk non-muscle-invasive bladder cancer (NMIBC) who have undergone initial transurethral resection of bladder tumor (TURBT) and are scheduled for second TURBT. Eligible tumors are urothelial carcinoma or bladder tumors with urothelial carcinoma as the predominant component (\>50%), with no evidence of muscle-invasive or metastatic disease.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead

Study Sites (2)

General Hospital of Tianjin Medical University

Tianjin, 300000, China

RECRUITING

The second hospital of Tianjin Medical University

Tianjin, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The genes of tumor exfoliated cells in urine

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Hailong Hu, MD

CONTACT

+8613662096232; hhllove2004@163.com

Yunkai Qie, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)