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

NCT ID: NCT07130578

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2025-12-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

urine tumor DNA/RNA testing

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

urine tumor DNA/RNA testing

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

Intervention Type: DIAGNOSTIC_TEST

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.

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

Exclusion Criteria

1. Contraindications to transurethral resection of bladder tumor (TURBT).

2. Concurrent malignancy of the upper urinary tract (ureter or renal pelvis).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Second Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The second hospital of Tianjin Medical University

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Hailong Hu, MD

Role: CONTACT

hhllove2004@163.com

+8613662096232

Yunkai Qie, MD

Role: CONTACT

Facility Contacts

Hailong Hu, MD

Role: primary

hhllove2004@163.com

+8613662096232

Other Identifiers

Truce-LB00

Identifier Type: -

Identifier Source: org_study_id