Genetic Risk Stratification of Pediatric Skin Lesions

Enrolling by invitation · Phase 1

Conditions studied: Skin Lesion, Nevus

In brief

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.

Key facts

Study ID

NCT05418959

Run by

Massachusetts General Hospital

People needed

100

Starts

2022-08-01

Expected to finish

2028-01-01

Last updated by the study team

2026-05-22

Who can join

Age: any, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• MGH Dermatology — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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