Evaluating the need for repeat bladder surgery in patients with negative urine biomarker tests
Official title: 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
Run by The First Affiliated Hospital with Nanjing Medical University · NCT06287541 · Data updated 2026-11-12
This study is testing if patients with non-muscle-invasive bladder cancer who have negative urine biomarker tests can skip repeat bladder surgery and still do well.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 428 (estimated) |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | July 1, 2023 |
| Main results expected | December 1, 2025 |
| Study ends | July 1, 2027 |
| Registry record updated | March 1, 2024 |
| Trial ID | NCT06287541 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with NMIBC who have tested negative for urine biomarkers after initial TURBT.
✕Probably not a fit
Patients with muscle-invasive bladder cancer or those unable to undergo a second transurethral resection will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates whether patients with non-muscle-invasive bladder cancer (NMIBC) who test negative for urine biomarkers can safely avoid a repeat transurethral resection of bladder tumor (reTURBT). Participants who have undergone an initial TURBT will be randomized into two groups: one group will not receive reTURBT, while the other will undergo the procedure. The study aims to compare recurrence-free survival rates between the two groups to determine if the urine biomarker test can effectively guide treatment decisions. The trial adheres to ethical guidelines and maintains participant confidentiality throughout the study.
Why it matters
Potential benefit: If successful, this study could help patients avoid unnecessary surgeries while maintaining their cancer management effectively.
How similar studies have gone: While there have been studies on urine biomarkers in bladder cancer, this specific approach to guiding reTURBT decisions is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China Recruiting
Study contacts
- Study coordinator: Qiang Lv, Ph.D
- Email: doctorlvqiang@sina.com
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.