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

ConditionsCutaneous Melanoma, Stage IICutaneous MelanomaAcral Melanoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of Nebraska

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Prior wide local excision of the lesion

History of melanoma

Melanoma lesions at more than one site

Prior radiation therapy to the site

Trial design

Design model

Parallel

Treatments tested in this trial

  • Wide Local Excision

    Diagnostic test

    Wide Local Excision

Treatment groups

282 Participants
are divided into 2 treatment groups
Group A: Standard BreadloafingActive comparator 1 intervention
Group B: Comprehensive Peripheral and Deep Margin AssessmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of positive peripheral margins

Tumor present at or near inked margin

Time frame
1 Month

Secondary outcomes

1

Local recurrence rate

In situ or invasive melanoma within 2 cm of the scar from treatment of the primary tumor

Time frame
1 and 2 years post-WLE
2

Re-excision rate

Need for repeat surgical intervention of the primary site to attain additional margins within 60 days of the index surgery

Time frame
2 months post-WLE, documented at 4-month post-WLE visit
3

Pathology turnaround time

From WLE date to final pathology report date

Time frame
Post-pathology report or 4-month follow-up
4

Pathology resource utilization

Number of tissue blocks and slides used

Time frame
Post-pathology report or 4-month follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Nebraska

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: