Genetic Risk Stratification of Pediatric Skin Lesions

Study Overview
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Brief Summary
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A study to understand the clinical utility of noninvasive adhesive skin biopsies in pediatric patients by exploring whether DermTech Pigmented Lesion Assay (PLA) genetic risk analysis of suspicious lesions in children correlates with histopathological diagnosis.

Detailed Description
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Patients (20 years of age or younger) with one or more atypical skin lesions requiring surgical biopsy within the next 6 months will be enrolled in the study. Prior to surgical biopsy, a DermTech PLA noninvasive adhesive will be performed on the lesion. The results of DermTech PLA genetic analysis will be compared to the results of histopathological diagnosis from surgical biopsy. Incidents of adverse events will also be collected.

Official Title
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Genetic Risk Stratification of Pediatric Skin Lesions

Conditions
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Skin Lesion, Nevus

Intervention / Treatment
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* Diagnostic Test: DermTech PLA noninvasive adhesive biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 years of age or younger. Subjects or parents willing and able to give informed consent, and assent as appropriate Patients will have one or more atypical skin lesions with management plan of monitoring, surgical biopsy, and/or excision of atypical nevi within the next 6 months Exclusion Criteria: Lesions on palms, soles, mucosal membranes, or area where hair cannot be trimmed Bleeding or ulcerated lesions Previously biopsied, scarred, or known melanoma lesions Presence of active psoriasis/eczema/other skin condition in area to be biopsied

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Non-invasive adhesive biopsies of suspicious skin lesions.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DermTech PLA noninvasive adhesive biopsy<br>Prior to surgical biopsy, a DermTech PLA noninvasive adhesive will be pressed over the lesion to collect superficial skin cells. | Diagnostic Test: DermTech PLA noninvasive adhesive biopsy<br>* The clinician will firmly press the DermTech noninvasive adhesive on the lesion and use their thumb to make five circular motions on the lesion. The adhesive patch will then be pulled off of the area. This will be repeated for an additional three patches.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or absence of PRAME genetic marker. | Presence or absence of PRAME genetic marker from PLA test | 1 day | 
| Presence or absence of LINC genetic marker. | Presence or absence of LINC genetic marker from PLA test | 1 da7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | No. of adverse events from adhesive skin biopsy. | 1 day |