Skin Lesion Clinical Trial
Official title:
Genetic Risk Stratification of Pediatric Skin Lesions
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | January 1, 2024 |
Est. primary completion date | January 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 20 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
Brouha B, Ferris LK, Skelsey MK, Peck G, Moy R, Yao Z, Jansen B. Real-World Utility of a Non-Invasive Gene Expression Test to Rule Out Primary Cutaneous Melanoma: A Large US Registry Study. J Drugs Dermatol. 2020 Mar 1;19(3):257-262. — View Citation
Jansen, B., Dobak, J. (2019) The Pigmented Lesion Assay Breakthrough: Enhanced Early Melanoma Detection with a Non-Invasive Gene Expression Test. DermTech, Inc. retrieved 4/11/20 from: https://dermtech.com/wp-content/uploads/PLA-TA.pdf
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence or absence of PRAME genetic marker. | Presence or absence of PRAME genetic marker from PLA test | 1 day | |
Primary | Presence or absence of LINC genetic marker. | Presence or absence of LINC genetic marker from PLA test | 1 da7 | |
Secondary | Incidence of Treatment-Emergent Adverse Events | No. of adverse events from adhesive skin biopsy. | 1 day |
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