Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06287541
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2024-02-23
Brief 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
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 12 into two groupsGroup 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
Detailed Description:
This clinical trial aims to address the clinical question of whether a urine biomarker test can effectively guide the decision-making process regarding the necessity of reTURBT repeat transurethral resection of bladder tumor in patients with non-muscle-invasive bladder cancer NMIBC The primary objective is to assess whether patients with negative urine biomarker tests can safely avoid reTURBT Participants eligible for enrollment in this study will be randomized in a 12 ratio into two groupsGroup A Participants assigned to this group will not undergo reTURBT They will receive standard follow-up care as per institutional guidelines Group B Participants assigned to this group will undergo reTURBT Following reTURBT they will also receive standard follow-up care The main task for participants will involve providing urine samples for the biomarker test before reTURBT Those in Group B will additionally undergo reTURBT a standard surgical procedure involving the removal of residual tumor tissue from the bladderThroughout the study period researchers will assess their recurrence-free survival rates and RFS The goal is to determine whether the urine biomarker test can safely spare patients from unnecessary reTURBT while maintaining comparable RFS rates This study adheres to ethical guidelines and has obtained approval from the appropriate institutional review boards Participant confidentiality and data integrity will be strictly maintained throughout the study duration The results of this trial have the potential to inform clinical practice guidelines and improve the management of NMIBC patients by offering a personalized approach to treatment decision-making
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None