Non Muscle Invasive Bladder Cancer Clinical Trial
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
NCT number | NCT06287541 |
Other study ID # | 2023-SR-486 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2023 |
Est. completion date | July 1, 2027 |
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.
Status | Recruiting |
Enrollment | 428 |
Est. completion date | July 1, 2027 |
Est. primary completion date | December 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital with Nanjing Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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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