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NCT07869381Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 9 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
282 (estimated)
First submitted
30 Sept 2026
Start date
24 Dec 2026
Primary completion date
24 Dec 2029
Lead sponsor
University of Nebraska
Diseases
Melanoma
NCT number
NCT07869381

What you commit to

  • Study type: Interventional
  • Planned participants: 282
  • From 24 Dec 2026 to the primary completion date, 24 Dec 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior wide local excision of the lesion
  • Prior radiation therapy to the site

Other illness

  • History of melanoma

Other

  • Melanoma lesions at more than one site
  • Pregnancy or lactation

Who the study is looking for

  • 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

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Nebraska Medical Center
Coordinator of this site? Confirm its status
OmahaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.