Genetic Risk Stratification of Pediatric Skin Lesions

Mass General Brigham

Status and phase

Not yet enrolling

Phase 1

Conditions

Nevus

Skin Lesion

Treatments

Diagnostic Test: DermTech PLA noninvasive adhesive biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT05418959

2022P001412

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

Under 20 years old

Volunteers

No Healthy Volunteers

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