NCT06287541 The Necessity of a Second Transurethral Resection in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection
| NCT ID | NCT06287541 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Condition | Non Muscle Invasive Bladder Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 428 participants |
| Start Date | 2023-07-01 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 428 participants in total. It began in 2023-07-01 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Qiang Lv, Ph.D
✉ doctorlvqiang@sina.comFrequently Asked Questions
Who can join the NCT06287541 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non Muscle Invasive Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06287541 currently recruiting?
Yes, NCT06287541 is actively recruiting participants. Contact the research team at doctorlvqiang@sina.com for enrollment information.
Where is the NCT06287541 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06287541 clinical trial?
NCT06287541 is sponsored by The First Affiliated Hospital with Nanjing Medical University. The trial plans to enroll 428 participants.
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