Actively Recruiting
The Necessity of a Second Transurethral Resection in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-03-01
428
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 �3e�3d 18 years
- Willingness to provide personal basic clinical information, as well as pathology and subsequent recurrence monitoring results
- Willingness to sign informed consent
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
Q
Qiang Lv, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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