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NOT YET RECRUITING
NCT07869381
NA

Trial Comparing CPDMA Versus Standard Breadloafing in WLE Specimens of Stage 1-II Cutaneous Melanoma

Sponsor: University of Nebraska

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

Wide Local Excision

Wide Local Excision

Locations (1)

University of Nebraska Medical Center

Omaha, Nebraska, United States