Genetic Risk Stratification of Pediatric Skin Lesions

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05418959
Study type	Interventional
Source	Massachusetts General Hospital
Contact	Elena B Hawryluk, MD, PhD
Phone	617-726-5066
Email	ehawryluk@partners.org
Status	Not yet recruiting
Phase	Phase 1
Start date	September 1, 2022
Completion date	January 1, 2024

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