Actively Recruiting
Guiding Value of Urinary Tumor DNA Testing in Cystoscopy for High-Risk/Very High-Risk Non-Muscle-Invasive Bladder Cancer
Led by Tianjin Medical University Second Hospital · Updated on 2026-05-11
360
Participants Needed
8
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 reduce the chance of the cancer coming back. Even with this treatment, high-grade NMIBC can return or progress, so patients need regular check-ups, usually with cystoscopy (a camera examination of the bladder) and urine cytology. Cystoscopy is effective but invasive, can cause discomfort, and carries risks such as infection and bleeding. This makes follow-up costly and sometimes burdensome for patients. This study is testing whether a urine tumor DNA (utDNA) test - a type of "liquid biopsy" that detects cancer-related DNA changes in urine - can help guide the timing of cystoscopy for people with high-risk or very high-risk NMIBC. utDNA testing is non-invasive and has shown high accuracy in detecting bladder cancer, sometimes spotting signs of recurrence earlier than standard methods. By combining utDNA testing with cystoscopy, we hope to safely reduce the number of unnecessary cystoscopies without missing cancer recurrences. The study will evaluate whether this approach can make bladder cancer follow-up more comfortable, more precise, and more efficient.
CONDITIONS
Official Title
Guiding Value of Urinary Tumor DNA Testing in Cystoscopy for High-Risk/Very High-Risk Non-Muscle-Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older
- Histologically confirmed high-risk or very high-risk non-muscle-invasive urothelial carcinoma of the bladder diagnosed within the past 2 years
- No evidence of muscle-invasive bladder cancer or metastatic disease
- Prior second transurethral resection of bladder tumor (re-TURBT), or complete initial TURBT with negative basal and peripheral margins and multiple site biopsies
- Pathological specimens including detrusor muscle showing no residual tumor
- Negative urine cytology at 2 weeks after surgery
You will not qualify if you...
- History of upper urinary tract malignancy (ureter or renal pelvis) within the past 5 years
- Concurrent diagnosis of upper urinary tract urothelial carcinoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Xingtai People's Hospital
Xingtai, Hebei, China
Actively Recruiting
2
Sun Yat-Sen Memorial Hosipital of Sun Yat-Sen University
Guangzhou, China
Actively Recruiting
3
The First Affiliated Hospital of Harbin Medical University
Haerbin, China
Actively Recruiting
4
The Second Affiliated Hospital of Kunming Medical University
Kunming, China
Actively Recruiting
5
Nanchang Second People's Hospital
Nanchang, China
Actively Recruiting
6
The second hospital of Tianjin Medical University
Tianjin, China, 300000
Actively Recruiting
7
General Hospital of Tianjin Medical University
Tianjin, China
Actively Recruiting
8
Tianjin Hospital
Tianjin, China
Actively Recruiting
Research Team
H
Hailong Hu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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