RecruitingNot ApplicableNCT07036731

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

A Prospective, Multicenter, Randomized 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


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

428 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study asks whether patients with high-risk non-muscle-invasive bladder cancer (cancer that stays in the bladder lining) who test negative on a special urine gene sequencing test after surgery actually need a second surgical procedure (re-resection) that is normally recommended. **You may be eligible if...** - You have non-muscle-invasive bladder cancer (NMIBC) and just had your first surgical removal of the tumor - You are scheduled for a second resection as recommended or by your doctor's choice - Your urine gene test result after the first surgery was negative **You may NOT be eligible if...** - Your cancer has already spread into the muscle layer of the bladder - You have already had multiple prior resections not covered by the study protocol - You have serious medical conditions preventing surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREUrine biomarker -Guided without reTURBT

Participants will proceed without reTURBT


Locations(1)

The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029

Nanjing, Jiangsu, China

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NCT07036731


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