NCT05418959

Genetic Risk Stratification of Pediatric Skin Lesions

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 0 Years – 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Skin Lesion
• Nevus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2022-06-14
• Last updated: 2022-06-14