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Trial Comparing CPDMA Versus Standard Breadloafing in WLE Specimens of Stage 1-II Cutaneous Melanoma
Sponsor: University of Nebraska
Summary
The primary goal of this clinical trial is to is to compare the rate of positive peripheral margins in wide local excision (WLE) performed to allow for comprehensive peripheral and deep margin assessment (CPDMA) assessment versus WLE performed with the intent of standard breadloafing of stage I-II cutaneous melanoma specimens. Secondary aims are to compare local recurrence at 1 and 2 years, the rate of re-excision due to positive margins, pathology turnaround time, pathology resource utilization, and cost per case between the two assessment methods. The main questions it aims to answer are: * Does WLE performed to allow for CPDMA have a higher rate of positive peripheral margins than wide local excision performed with the intent of standard breadloafing? * Will more complete positive margin detection support more appropriate re-excision and lower local recurrence over two years? * Does CPDMA require greater pathology resource utilization and longer turnaround time than breadloafing? Researchers will compare standard breadloafing (control) arm to CPDMA (experimental) arm. Participants will: * Undergo WLE. * Attend a follow-up visit at 4 months.
Official title: A Randomized Controlled Trial Comparing Comprehensive Peripheral Deep Margin Assessment Versus Standard Breadloafing in Wide Local Excision Specimens of Clinical Stage I-II Cutaneous Melanoma
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
282
Start Date
2026-12-24
Completion Date
2031-12-24
Last Updated
2026-10-09
Healthy Volunteers
No
Interventions
Wide Local Excision
Wide Local Excision
Locations (1)
University of Nebraska Medical Center
Omaha, Nebraska, United States