Actively Recruiting
A Study Comparing the Necessity of a Second Transurethral Resection in High-Risk Non-Muscle-Invasive Bladder Cancer Patients With Negative Results From Post-Initial Resection Urine Genome-Wide Low-Depth Sequencing
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-06-25
428
Participants Needed
1
Research Sites
238 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, randomized, multicenter clinical trial aiming to enroll 428 patients with non-muscle-invasive bladder cancer (NMIBC) from the Department of Urology at Jiangsu Provincial People's Hospital and its affiliated centers, who have undergone their initial transurethral resection and are scheduled for a second resection. Within 1-6 weeks after the first resection and prior to the second resection, 100ml of routine urine will be collected and sent within 24 hours to Beijing Genetron Health Clinical Laboratory Co., Ltd. for the extraction of urinary sediment DNA, which will then undergo genome-wide low-depth sequencing. Patients with positive test results will proceed with the second resection, while those with negative results will be randomly assigned in a 1:2 ratio to either the intervention group, which will not undergo a second resection, or the control group, which will undergo the second resection. All enrolled patients will be followed up for two years. The study will statistically analyze and compare the two-year recurrence-free survival rates between the two groups and evaluate the predictive capability of the test results for follow-up recurrence.
CONDITIONS
Official Title
A Study Comparing the Necessity of a Second Transurethral Resection in High-Risk Non-Muscle-Invasive Bladder Cancer Patients With Negative Results From Post-Initial Resection Urine Genome-Wide Low-Depth Sequencing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with non-muscle-invasive bladder cancer who have completed the initial transurethral resection and are scheduled for a second resection based on guidelines or physician's advice
- Initial resection was incomplete due to reasons like large tumor size or risk of bleeding
- Initial resection specimen lacks muscle layer tissue
- Pathology after initial resection shows T1 stage
- Pathology after initial resection shows G3/high-grade tumor, excluding pure carcinoma in situ
- Able to provide 100ml urine sample within 1 to 6 weeks after initial resection and before second resection
- Age 18 years or older
- Willing to provide clinical information, pathology, and recurrence monitoring data
- Willing to sign informed consent form
You will not qualify if you...
- Presence of other non-urothelial malignant tumors such as prostate or kidney cancer
- Previous diagnosis of muscle-invasive bladder cancer
- Unable to undergo second resection
- Incomplete pathological information of the sample
- Contaminated samples
- Urine samples failing quality control and cannot be resampled
- Any condition that may harm the participant or prevent study compliance as judged by the investigator
- Unable to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
Y
Yang xiao, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here