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NCT Number: NCT07187635

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

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.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Liquid Biopsy Male Urogenital Diseases Neoplasms Neoplasms by Site Repeat Transurethral Resection of Bladder Tumor 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

Interventional

Phase

Not applicable

Primary location

Nanchang Second People's Hospital, Nanchang, Anhui, China

Loading trial locations.

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.

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

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.

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.

Primary outcomes

  1. Recurrence-free survival (RFS)

    Time frame: Up to 24 months from randomization

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

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: Up to 24 months from randomization

    Time from initial TURBT to disease progression (development of muscle-invasive bladder cancer, distant metastasis).

  2. Pathological outcomes of second transurethral resection (re-TURBT)

    Time frame: Perioperative (day of repeat TURBT)

    Proportion of patients with residual tumor, upstaging (higher T category at re-TURBT), or concomitant CIS among those undergoing repeat TURBT.

  3. Patient-reported outcomes

    Time frame: Up to 24 months from randomization.

    Health outcomes directly reported by the patient without interpretation by clinicians or others. These measures capture patients' perceptions of symptoms, functional status, health-related quality of life (HRQoL), and treatment-related burden.

Other outcomes

  1. Correlation Between utDNA Status and Clinical Outcomes

    Time frame: Up to 24 months from randomization

    Association of urine utDNA results with cystoscopy findings, imaging results, and re-TURBT pathology; evaluation of diagnostic performance (sensitivity, specificity, predictive values, AUC) and relation to recurrence/progression.

Study contacts

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

Hailong Hu, MD

CONTACT

[email protected]

+8613662096232

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Second Hospital

Other

Registry information

Official study title

The Guiding Value of Urinary Tumor DNA Testing in Repeat Transurethral Resection of Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized Controlled, Multi-Center Clinical Study (Truce-LB01)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 23, 2025
Registry last updated
May 11, 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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