Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525571
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Comparing white-light cystoscopy WLC and blue-light cystoscopy BLC in TURBT for high risk HR non-muscle invasive bladder cancer NMIBC patients is crucial to determine the most effective method for reducing residual disease burden and improving recurrence-free survival Enhanced visualization with BLC may lead to more accurate resections potentially decreasing recurrence rates and improving long-term outcomes for bladder cancer patients Patients will be randomized to either WLC TURBT or BLC TURBT and outcomes will be measured using standard-of-care testing with cystoscopy and cytology along with minimal residual disease MRD burden evaluation using urine next-generation sequencing
Detailed Description:
Objectives are as follows
Primary i Comparison of the reduction in MRD burden score between pre-resection and post-resection urine samples across BLC and WLC resection arms of the study and among patients with a high-grade tumor at time of resection ii Comparison of the reduction in MRD burden score between pre-resection and post-resection urine samples across BLC and WLC resection arms of the study and among all evaluable study participants
Secondary i Among all evaluable study participants Recurrence-free survival RFS at 12 and 24 months using post-TURBT and three month surveillance urine sample time points in BLC and WLC arm
ii Among patients undergoing intravesical induction Recurrence-free survival RFS at 12 and 24 months using post-TURBT and three month surveillance urine sample time points in BLC and WLC arm
Primary i Comparison of the reduction in MRD burden score between pre-resection and post-resection urine samples across BLC and WLC resection arms of the study and among patients with a high-grade tumor at time of resection ii Comparison of the reduction in MRD burden score between pre-resection and post-resection urine samples across BLC and WLC resection arms of the study and among all evaluable study participants
Secondary i Among all evaluable study participants Recurrence-free survival RFS at 12 and 24 months using post-TURBT and three month surveillance urine sample time points in BLC and WLC arm
ii Among patients undergoing intravesical induction Recurrence-free survival RFS at 12 and 24 months using post-TURBT and three month surveillance urine sample time points in BLC and WLC arm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None