RecruitingNot Applicable

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

China428 participantsStarted 2023-07-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

2-year RFS rate

Timeframe: from initial TURBT to the first confirmed recurrence within 2 years

Trial details

NCT IDNCT06287541

SponsorThe First Affiliated Hospital with Nanjing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01

Contact for this trial

Qiang Lv, Ph.D

doctorlvqiang@sina.com