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RECRUITING
NCT06287541
NA

The Necessity of a Second Transurethral Resection 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

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

428

Start Date

2023-07-01

Completion Date

2027-07-01

Last Updated

2024-03-01

Healthy Volunteers

No

Interventions

PROCEDURE

Urine biomarker -Guided without reTURBT

Participants will proceed without reTURBT

Locations (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China