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

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT07869381
Status
Not Yet Recruiting

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Conditions

  • Acral Melanoma
  • Cutaneous Melanoma
  • Cutaneous Melanoma, Stage II

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Wide Local Excision — DIAGNOSTIC_TEST
    Wide Local Excision

Study Details

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.

Key Dates

First listed
Oct 9, 2026
Start date
Dec 24, 2026
Status verified
Sep 2026
Primary completion
Dec 24, 2029
Completion
Dec 24, 2031

Study Design

Enrollment
282 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Standard Breadloafing
    Control Arm
  • Experimental: Comprehensive Peripheral and Deep Margin Assessment
    Experimental Arm

Primary Outcome Measure

Rate of positive peripheral margins [ Time Frame: 1 Month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical CenterOmahaNebraska68198
IIT Office
[email protected]
402-559-4596
Joshua Mammen (PRINCIPAL_INVESTIGATOR)

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By research site
University of Nebraska Medical Center· Omaha, NE

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