RecruitingNot ApplicableNCT06287541

The Necessity of a Second Transurethral Resection in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection

A Prospective, Multicenter, Randomized Study Comparing the Necessity of a Second Transurethral Resection of Bladder Tumor in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

428 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

Non Muscle Invasive Bladder Cancer

Summary

The goal of this clinical trial is to evaluate the efficacy of using a urine biomarker test to guide the decision-making process regarding the necessity of reTURBT in NMIBC patients. The main question aims to answer whether patients with negative urine biomarker tests can safely avoid reTURBT without compromising recurrence-free survival. Participants who have completed the initial TURBT and tested negative for the urine biomarker will be enrolled in the study. They will then be randomized 1:2 into two groups:Group A: Participants will not receive reTURBT and Group B: Participants will undergo reTURBT. Researchers will compare the RFS rates between Group A (no reTURBT) and Group B (reTURBT) to determine if the urine biomarker test can safely spare patients from unnecessary reTURBT.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether patients with high-risk non-muscle-invasive bladder cancer who test negative for cancer markers in their urine still need a second surgery (re-resection) after their initial tumor removal. **You may be eligible if...** - You have been diagnosed with high-risk non-muscle-invasive bladder cancer - You have already had initial bladder tumor removal surgery (TURBT) and are scheduled for a second resection - Your urine biomarker test after the first surgery came back negative - You are 18 or older and willing to share your clinical and follow-up information **You may NOT be eligible if...** - You have another urological cancer (such as prostate cancer or kidney cancer) - You previously had muscle-invasive bladder cancer - You are unable to undergo a second surgery - Your pathology records are incomplete 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, China

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NCT06287541

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