Genetic Risk Stratification of Pediatric Skin Lesions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DermTech PLA noninvasive adhesive biopsy.
- Who it may be relevant to
- Registry conditions: Skin Lesion, Nevus. Basic parameters: 0 years — 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 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.
Primary outcome measures
- Presence or absence of PRAME genetic marker. [Time frame: 1 day]
- Presence or absence of LINC genetic marker. [Time frame: 1 da7]
Secondary outcome measures (1)
- Incidence of Treatment-Emergent Adverse Events [Time frame: 1 day]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- MGH Dermatology — Boston
Publications
- 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
- 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. No abstract available. PMID 32550693
Identifiers
NCT: NCT05418959 · 2022P001412