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

NCT07869381 — Not applicable, Not yet recruiting, 282 participants, University of Nebraska

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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

Registry	NCT07869381
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, diagnostic
Enrollment	282 (Estimated)
Sponsor	University of Nebraska (Other)
Conditions	Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Acral Melanoma
Interventions	Wide Local Excision (Diagnostic test)
Dates	start 2026-12-24 (estimated), primary completion 2029-12-24 (estimated), completion 2031-12-24 (estimated), first posted 2026-10-09, last updated 2026-10-09
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Standard Breadloafing	Active comparator	Diagnostic Test: Wide Local Excision	Control Arm
Comprehensive Peripheral and Deep Margin Assessment	Experimental	Diagnostic Test: Wide Local Excision	Experimental Arm

Wide Local Excision (Diagnostic test): Wide Local Excision

+Outcome measures

Primary outcomes

Rate of positive peripheral margins [1 Month]: Tumor present at or near inked margin

Secondary outcomes

Local recurrence rate [1 and 2 years post-WLE]: In situ or invasive melanoma within 2 cm of the scar from treatment of the primary tumor
Re-excision rate [2 months post-WLE, documented at 4-month post-WLE visit]: Need for repeat surgical intervention of the primary site to attain additional margins within 60 days of the index surgery
Pathology turnaround time [Post-pathology report or 4-month follow-up]: From WLE date to final pathology report date
Pathology resource utilization [Post-pathology report or 4-month follow-up]: Number of tissue blocks and slides used
Pathologist time [1 Month]: Start of specimen review to end of specimen review
Technician time [1 Month]: Opening container to closing the block
Cost per case [2 years post-WLE]: Total amount billed

+Eligibility

Sex: All, ages: 19 Years to any

Inclusion Criteria:

* 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 Criteria:

* 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

+Locations (1)

Facility	City	Country	Status
University of Nebraska Medical Center	Omaha, Nebraska	United States

+Investigators

Joshua Mammen, Principal investigator, University of Nebraska