Genetic Risk Stratification of Pediatric Skin Lesions

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05418959
Phase
PHASE1
Status
Enrolling By Invitation

Conditions

  • Nevus
  • Skin Lesion

Eligibility Criteria

Sex
ALL
Age
0 Years - 20 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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 Dates

Start date
Aug 1, 2022
Status verified
May 2026
Primary completion
Jan 1, 2028
Completion
Jan 1, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 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 Measure

Presence or absence of PRAME genetic marker. [ Time Frame: 1 day ]

Locations (1)

FacilityCityStateZIPSite coordinators
MGH DermatologyBostonMassachusetts02482-

Find similar trials in Boston, MA

By research site
MGH Dermatology· Boston, MA

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