Tests whether a urine test can avoid a second bladder surgery
Tests a urine test to decide on repeat bladder surgery in adults with bladder cancer.
Plain-language title generated from the registry record
Registry title: The Necessity of a Second Transurethral Resection in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection
Key facts
- Where
- Nanjing, ChinaSee the site
Where in China
- The First Affiliated Hospital of Nanjing Medical UniversityNanjing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The First Affiliated Hospital with Nanjing Medical University
- Trial code
- NCT06287541
- Record updated
- 1 March 2024
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Patients previously diagnosed with muscle-invasive bladder cancer; Patients unable to undergo a second transurethral resection; Patients with other non-urothelial malignant tumors (including prostate cancer and renal cell carcinoma); Any condition perceived by the researcher to potentially harm the subjects or prevent them from meeting or executing the study requirements; Patients with incomplete sample pathology information; Patients unable to provide written informed consent.