Genetic Risk Stratification of Pediatric Skin Lesions

Phase 1

• Conditions: Skin Lesion; Nevus
• Interventions: Diagnostic Test: DermTech PLA noninvasive adhesive biopsy

• Registration Number: NCT05418959
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-09
• Study First Submitted QC: 2022-06-13
• Last Update Submitted: 2022-06-13
• Study First Posted: 2022-06-14
• Last Update Posted: 2022-06-14
• Study Start: 2022-09-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DermTech PLA noninvasive adhesive biopsy	DermTech PLA noninvasive adhesive biopsy	Prior to surgical biopsy, a DermTech PLA noninvasive adhesive will be pressed over the lesion to collect superficial skin cells.

Primary Outcome Measures

Name	Time	Method
Presence or absence of PRAME genetic marker.	1 day	Presence or absence of PRAME genetic marker from PLA test
Presence or absence of LINC genetic marker.	1 da7	Presence or absence of LINC genetic marker from PLA test

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	1 day	No. of adverse events from adhesive skin biopsy.