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

RecruitingNAAges 18 Years - anyAllThe First Affiliated Hospital with Nanjing Medica…
NCT06287541 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Urine biomarker -Guided without reTURBT
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Where

1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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