Guiding Value of Urinary Tumor DNA Testing in Repeat Transurethral Resection of Non-Muscle-Invasive Bladder Cancer

NCT07187635 | Recruiting

• 1 other identifier: Truce-LB01
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 2

Brief Summary

Non-muscle-invasive bladder cancer (NMIBC) accounts for approximately 75% of newly diagnosed bladder cancers and is characterized by a high risk of recurrence and progression. Current guidelines recommend that patients with stage T1 NMIBC undergo a second transurethral resection of bladder tumor (re-TURBT) within 2-6 weeks after the initial surgery to remove residual tumor, confirm staging, and obtain additional pathological information. However, the benefits of routine re-TURBT for all high-risk patients remain controversial, as many patients may not have residual disease, while the procedure carries surgical and anesthetic risks, physical and psychological burden, and additional healthcare costs. Urine tumor DNA (utDNA) refers to DNA fragments shed by tumor cells into urine. It can be detected using molecular assays with high sensitivity and specificity, offering a non-invasive method for bladder cancer diagnosis and surveillance. Previous studies have shown that positive utDNA results after initial TURBT may be associated with residual disease and higher recurrence risk. This multicenter, randomized controlled trial aims to evaluate whether utDNA testing can accurately identify NMIBC patients who are most likely to benefit from re-TURBT, thereby guiding the decision to perform the procedure. The goal is to optimize patient selection for re-TURBT, reduce unnecessary surgeries, and improve patient quality of life while maintaining oncologic safety.

Conditions

Bladder Cancer; Liquid Biopsy; Repeat Transurethral Resection of Bladder Tumor

Keywords

bladder cancer; liquid biopsy; second transurethral resection of bladder tumor

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival (RFS)

  Time from randomization to the first documented event of bladder tumor recurrence (any grade), upper tract urothelial recurrence.

  Up to 24 months from randomization

Secondary Outcomes (3)

• Progression-free survival (PFS)

  Up to 24 months from randomization

• Pathological outcomes of second transurethral resection (re-TURBT)

  Perioperative (day of repeat TURBT)

• Patient-reported outcomes

  Up to 24 months from randomization.

Other Outcomes (1)

• Correlation Between utDNA Status and Clinical Outcomes

  Up to 24 months from randomization

Study Arms (2)

Standard re-TURBT

ACTIVE COMPARATOR

Participants with NMIBC who have undergone initial TURBT will not receive utDNA testing and will undergo a second transurethral resection of bladder tumor (re-TURBT) within 2-6 weeks after the initial surgery, per guideline-based management.

Procedure: Second Transurethral Resection of Bladder Tumor (re-TURBT)

utDNA-guided management

EXPERIMENTAL

Participants with NMIBC who have undergone initial TURBT will receive urine tumor DNA (utDNA) testing. If utDNA positive, they will undergo re-TURBT within 2-6 weeks after the initial surgery. If utDNA negative, re-TURBT will be omitted and patients will continue guideline-based adjuvant therapy/surveillance as per protocol.

Diagnostic Test: utDNA Testing (Urine Tumor DNA Detection)

Interventions

Second Transurethral Resection of Bladder Tumor (re-TURBT) PROCEDURE

Participants with NMIBC who have undergone initial TURBT will not receive utDNA testing and will undergo a second transurethral resection of bladder tumor (re-TURBT) within 2-6 weeks after the initial surgery, in accordance with current clinical guidelines.

Standard re-TURBT

utDNA Testing (Urine Tumor DNA Detection) DIAGNOSTIC_TEST

Participants with NMIBC who have undergone initial TURBT will receive urine tumor DNA (utDNA) testing. If utDNA is positive, the patient will undergo a second transurethral resection of bladder tumor (re-TURBT) within 2-6 weeks after the initial surgery. If utDNA is negative, re-TURBT will be omitted and patients will proceed to guideline-based adjuvant therapy or surveillance.

utDNA-guided management

Eligibility Criteria

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

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.

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)

The second hospital of Tianjin Medical University

Tianjin, 300000, China

RECRUITING

General Hospital of Tianjin Medical University

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Urinary 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

Central Study Contacts

Hailong Hu, MD

CONTACT

+8613662096232; huhailong@tmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 23, 2025
• Study Start: September 28, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

CN (2)