Status:

RECRUITING

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

Lead Sponsor:

Tianjin Medical University Second Hospital

Conditions:

Bladder Cancer

Liquid Biopsy

Eligibility:

All Genders

18+ years

Phase:

NA

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 recom...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

July 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2027

Estimated Enrollment :

196 Patients enrolled

Trial Details

Trial ID

NCT07187635

Start Date

July 1 2025

End Date

October 1 2027

Last Update

September 23 2025

Active Locations (1)

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1

The second hospital of Tianjin Medical University

Tianjin, China, 300000