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

NCT06287541 · tracked via the Priya Life Science China tracker

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Phase

Not applicable

Started

2023-07-01

Last updated

2024-03-01

Condition(s) studied

Non Muscle Invasive Bladder Cancer

Investigational drug(s) / intervention(s)

Urine biomarker -Guided without reTURBT

Urine biomarker -Guided without reTURBT: Participants will proceed without reTURBT

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patients with NMIBC who have undergone initial TURBT and are scheduled for reTURBT surgery as recommended by guidelines or chosen by their physicians; * Patients who have tested negative for urine biomarkers after the initial TURBT and before the second TURBT; * Age ≥ 18 years; * Willingness to provide personal basic clinical information, as well as pathology and subsequent recurrence monitoring results; * Willingness to sign informed consent. Exclusion Criteria: * Patients with other non-urothelial malignant tumors (including prostate cancer and renal cell carcinoma); * Patients previously diagnosed with muscle-invasive bladder cancer; * Patients unable to undergo a second transurethral resection; * Patients with incomplete sample pathology information; * Any condition perceived by the researcher to potentially harm the subjects or prevent them from meeting or executing the study requirements; * Patients unable to provide written informed consent.

Primary outcome measure(s)

2-year RFS rate — from initial TURBT to the first confirmed recurrence within 2 years
the proportion of participants experiencing a recurrence during follow-up within 2 years

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu	Recruiting

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Is Prolonged Systemic Immunotherapy Necessary After Achieving Tumor-free Status in Patients With Extensive Transurethrally Unresectable Very-high-risk NMIBC? Starting soon

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06287541 on ClinicalTrials.gov ↗ ← All trials in China