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OpenTrials
Enrolling by Invitation

NCT Number: NCT05418959

Genetic Risk Stratification of Pediatric Skin Lesions

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.

Enrolling by Invitation

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Key information

Conditions

Skin Lesion Neoplasms Neoplasms by Histologic Type Nevi and Melanomas Nevus

Age range

0 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MGH Dermatology

Boston, Massachusetts, 02482, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DermTech PLA noninvasive adhesive biopsy

Diagnostic Test

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.

Primary outcomes

  1. Presence or absence of PRAME genetic marker.

    Time frame: 1 day

    Presence or absence of PRAME genetic marker from PLA test

  2. Presence or absence of LINC genetic marker.

    Time frame: 1 da7

    Presence or absence of LINC genetic marker from PLA test

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: 1 day

    No. of adverse events from adhesive skin biopsy.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Jun 14, 2022
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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