Status:
RECRUITING
Guiding Value of Urinary Tumor DNA Testing in Cystoscopy for High-Risk/Very High-Risk 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) is usually treated with surgery to remove the tumor (transurethral resection of bladder tumor, or TURBT), often followed by bladder-instilled medications to ...
Eligibility Criteria
Inclusion
- Male or female participants aged 18 years or older.
- Histologically confirmed high-risk or very high-risk non-muscle-invasive urothelial carcinoma (NMIBC) of the bladder, as defined by the EAU 2025 NMIBC guidelines, or bladder tumors in which high-risk/very high-risk NMIBC constitutes more than 50% of the pathological composition, diagnosed within the past 2 years, with no evidence of muscle-invasive bladder cancer or metastatic disease.
- Prior to enrollment, participants must have undergone either:
- A.Second transurethral resection of bladder tumor (re-TURBT), or B.Complete initial TURBT with negative basal margins, peripheral margins, and multiple site biopsies, with pathological specimens including detrusor muscle and showing no residual tumor, and negative urine cytology at 2 weeks post-surgery.
Exclusion
- History of upper urinary tract malignancy (ureter or renal pelvis) within the past 5 years or concurrent diagnosis of upper urinary tract urothelial carcinoma.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT07180212
Start Date
July 1 2025
End Date
September 1 2027
Last Update
December 3 2025
Active Locations (1)
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1
The second hospital of Tianjin Medical University
Tianjin, China, 300000