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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urine biomarker -Guided without reTURBT | Experimental | Participants in this arm will proceed without reTURBT if Urine biomarker tested negative |
|
| Standard Care with reTURBT | No Intervention | Participants in this arm will receive standard care, which undergo reTURBT |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urine biomarker -Guided without reTURBT | Procedure | Participants will proceed without reTURBT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-year RFS rate | the proportion of participants experiencing a recurrence during follow-up within 2 years | from initial TURBT to the first confirmed recurrence within 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from initial TURBT to the first confirmed recurrence within 2 years |
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Inclusion Criteria:
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:
Ability to provide a 100ml routine urine sample within 1-6 weeks after the initial resection and before the second resection;
Age ≥ 18 years;
Willingness to provide basic clinical information, pathology, and subsequent - recurrence monitoring results;
Willingness to sign the informed consent form.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang xiao, PhD | Contact | +8613951813528 | yangxiao2915@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029 | Recruiting | Nanjing | Jiangsu | China |
all IPD that underlie results in a publication
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Participants who meet the inclusion criteria are randomized 1:2 into two parallel groups. Group A: Participants assigned to this group will not undergo reTURBT. They will receive standard follow-up care as per institutional guidelines.
Group B: Participants assigned to this group will undergo reTURBT as part of their treatment protocol. Following reTURBT, they will also receive standard follow-up care. Outcome measures of recurrence rate and RFS would be compared between the two groups to determine the effectiveness and safety of the urine genetic test-guided approach compared to standard care with reTURBT.Throughout the study period, both groups are followed up simultaneously, allowing for parallel comparisons of outcomes.
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| ID | Term |
|---|---|
| D000093284 | Non-Muscle Invasive Bladder Neoplasms |
| D005198 | Fanconi Syndrome |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D015499 | Renal Tubular Transport, Inborn Errors |
| D007674 | Kidney Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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