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Genetic Risk Stratification of Pediatric Skin Lesions

NCT05418959 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Skin Lesion
  • Nevus

Interventions

DIAGNOSTIC_TEST

DermTech PLA noninvasive adhesive biopsy

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.

Sponsors & Collaborators

Principal Investigators

  • Elena B Hawryluk, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2028-01-01
Completion
2028-01-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05418959 on ClinicalTrials.gov