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

NCT07869381 | Not Yet Recruiting DMC

• 1 other identifier: CPMABREAD
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cutaneous Melanoma, Stage II; Cutaneous Melanoma; Acral Melanoma

Keywords

Cutaneous Melanoma; Breadloafing; CPDMA; Wide Local Excision

Outcome Measures

Primary Outcomes (1)

• Rate of positive peripheral margins

  Tumor present at or near inked margin

  1 Month

Secondary Outcomes (7)

• Local recurrence rate

  1 and 2 years post-WLE

• Re-excision rate

  2 months post-WLE, documented at 4-month post-WLE visit

• Pathology turnaround time

  Post-pathology report or 4-month follow-up

• Pathology resource utilization

  Post-pathology report or 4-month follow-up

• Pathologist time

  1 Month

Study Arms (2)

Standard Breadloafing

ACTIVE COMPARATOR

Control Arm

Diagnostic Test: Wide Local Excision

Comprehensive Peripheral and Deep Margin Assessment

EXPERIMENTAL

Experimental Arm

Diagnostic Test: Wide Local Excision

Interventions

Wide Local Excision DIAGNOSTIC_TEST

Wide Local Excision

Comprehensive Peripheral and Deep Margin Assessment; Standard Breadloafing

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior wide local excision of the lesion
• History of melanoma
• Melanoma lesions at more than one site
• Prior radiation therapy to the site
• Pregnancy or lactation

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Joshua Mammen

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

IIT Office

CONTACT

402-559-4596; iitoffice@unmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): December 24, 2026
• Primary Completion (Estimated): December 24, 2029
• Study Completion (Estimated): December 24, 2031
• Last Updated: October 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)