Status:
UNKNOWN
Genetic Risk Stratification of Pediatric Skin Lesions
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Skin Lesion
Nevus
Eligibility:
All Genders
Up to 20 years
Phase:
PHASE1
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 le...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05418959
Start Date
September 1 2022
End Date
January 1 2024
Last Update
June 14 2022
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