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Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection

StatusRecruiting
PhasePhase 3
Started2024-12-20
View on ClinicalTrials.gov ↗

Amendment history

2025-11-17
Study Status, Contacts/Locations v6
Re-verified, no change to tracked fields
2025-01-09
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v5
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-01-04→confirmed 2024-12-20
Study sites0→2
2024-11-07
Study Status v4
Primary completion date2026-11-04→2027-01-04
Completion date2027-11-04→2028-01-04
Start date2024-11-04→2025-01-04
2024-10-16
Study Status v3
Primary completion date2026-10-04→2026-11-04
Completion date2027-10-04→2027-11-04
Start date2024-10-04→2024-11-04
2024-09-05
Study Status v2
Primary completion date2026-08→2026-10-04
Completion date2027-08→2027-10-04
Start date2024-08→2024-10-04
2024-07-29
Study Status, Conditions v1
Re-verified, no change to tracked fields
2024-07-24
Original filing
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.
Trial Details
NCT Number NCT06525571
Lead Sponsor Johns Hopkins University
Collaborators: Photocure ASA
Conditions Bladder Cancer
Enrollment 200 participants
Start Date 2024-12-20
Primary Completion 2027-01-04 (estimated)
Study Completion 2028-01-04 (estimated)
Updated on ClinicalTrials.gov 2025-11-18