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
The First Affiliated Hospital with Nanjing Medical University
428 participants
Jul 1, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria6
- 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.
Interventions
Participants will proceed without reTURBT
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06287541