Nevus, Skin Lesion
Conditions
Brief 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.
Detailed 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.
Interventions
DIAGNOSTIC_TESTDermTech 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
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Non-invasive adhesive biopsies of suspicious skin lesions.
Eligibility
Sex/Gender
ALL
Age
0 Years to 20 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence or absence of PRAME genetic marker. | 1 day | Presence or absence of PRAME genetic marker from PLA test |
| Presence or absence of LINC genetic marker. | 1 da7 | Presence or absence of LINC genetic marker from PLA test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 1 day | No. of adverse events from adhesive skin biopsy. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElena B Hawryluk, MD, PhD
Massachusetts General Hospital
Outcome results
None listed