An interventional study of Urine biomarker -Guided without reTURBT in Non Muscle Invasive Bladder Cancer, sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-25.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Treatment
This study is a prospective, randomized, multicenter clinical trial aiming to enroll 428 patients with non-muscle-invasive bladder cancer (NMIBC) from the Department of Urology at Jiangsu Provincial People's Hospital and its affiliated centers, who have undergone their initial transurethral resection and are scheduled for a second resection. Within 1-6 weeks after the first resection and prior to the second resection, 100ml of routine urine will be collected and sent within 24 hours to Beijing Genetron Health Clinical Laboratory Co., Ltd. for the extraction of urinary sediment DNA, which will then undergo genome-wide low-depth sequencing. Patients with positive test results will proceed with the second resection, while those with negative results will be randomly assigned in a 1:2 ratio to either the intervention group, which will not undergo a second resection, or the control group, which will undergo the second resection. All enrolled patients will be followed up for two years. The study will statistically analyze and compare the two-year recurrence-free survival rates between the two groups and evaluate the predictive capability of the test results for follow-up recurrence.
Patients with NMIBC who have completed the initial transurethral resection and are scheduled for a second resection, as recommended by guidelines or physician's choice:
Exclusion Criteria:
Participants in this arm will proceed without reTURBT if Urine biomarker tested negative
Procedure: Urine biomarker -Guided without reTURBT
Participants in this arm will receive standard care, which undergo reTURBT
Participants will proceed without reTURBT
2-year RFS rate
the proportion of participants experiencing a recurrence during follow-up within 2 years
Time frame: from initial TURBT to the first confirmed recurrence within 2 years
RFS
the duration from the completion of initial TURBT until the first recurrence of cancer is detected or until the end of the follow-up period, whichever comes first.
Time frame: from initial TURBT to the first confirmed recurrence within 2 years
Plan to share: Yes — all IPD that underlie results in a publication
Supporting information: Study protocol, Csr
No publications or documents are linked to this record.
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Non-Muscle Invasive Bladder Neoplasms→
The First Affiliated Hospital with Nanjing Medical University