Actively Recruiting
Guiding Value of Urinary Tumor DNA Testing in Repeat Transurethral Resection of Non-Muscle-Invasive Bladder Cancer
Led by Tianjin Medical University Second Hospital · Updated on 2026-05-11
196
Participants Needed
6
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Guiding Value of Urinary Tumor DNA Testing in Repeat Transurethral Resection of Non-Muscle-Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Histologically confirmed non-muscle-invasive bladder tumor without muscle-invasive or metastatic disease
- Histologically confirmed urothelial carcinoma of the bladder or tumor with over 50% urothelial carcinoma
- At least one of the following: incomplete initial TURBT or suspected incomplete resection; absence of detrusor muscle in initial TURBT specimen (except low-grade Ta or carcinoma in situ); T1 stage tumor
- Willingness to provide a 50 mL urine sample between 2-6 weeks after initial TURBT and before re-TURBT
- Willingness to provide tumor tissue samples for pathological examination
- Willingness to undergo genetic testing required for the trial
You will not qualify if you...
- Contraindications to transurethral resection of bladder tumor (TURBT)
- Concurrent malignancy of the upper urinary tract (ureter or renal pelvis)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Nanchang Second People's Hospital
Nanchang, Anhui, China
Actively Recruiting
2
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
3
Xingtai People's Hospital
Xingtai, Hebei, China
Actively Recruiting
4
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Actively Recruiting
5
The second hospital of Tianjin Medical University
Tianjin, China, 300000
Actively Recruiting
6
General Hospital of Tianjin Medical University
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
TREATMENT
Number of Arms
2
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