Two Ways of Checking Removed Tissue in Early-Stage Skin Melanoma
Compares two ways of examining removed tissue for cancer cells in melanoma surgery.
Plain-language title generated from the registry record
Registry title: Trial Comparing CPDMA Versus Standard Breadloafing in WLE Specimens of Stage 1-II Cutaneous Melanoma
Key facts
- Where
- Omaha, United StatesSee the site
Where in United States
- University of Nebraska Medical CenterOmaha, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Nebraska
- Trial code
- NCT07869381
- Record updated
- 9 October 2026
- Original description
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:Read full original descriptionShow less
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
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.
Inclusion: Age ≥19 years; Histologically confirmed clinical Stage I or II cutaneous melanoma, inclusive of acral melanoma; Candidate for guideline (NCCN) concordant wide local excision; Able to provide informed consent.
Exclusion: Prior wide local excision of the lesion; Prior radiation therapy to the site; History of melanoma; Melanoma lesions at more than one site; Pregnancy or lactation.