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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DermTech PLA noninvasive adhesive biopsy | Experimental | Prior to surgical biopsy, a DermTech PLA noninvasive adhesive will be pressed over the lesion to collect superficial skin cells. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DermTech PLA noninvasive adhesive biopsy | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Presence or absence of PRAME genetic marker. | Presence or absence of PRAME genetic marker from PLA test | 1 day |
| Presence or absence of LINC genetic marker. | Presence or absence of LINC genetic marker from PLA test | 1 da7 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | No. of adverse events from adhesive skin biopsy. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena B Hawryluk, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MGH Dermatology | Boston | Massachusetts | 02482 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 32550693 | Background | 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. |
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| ID | Term |
|---|---|
| D009506 | Nevus |
| ID | Term |
|---|---|
| D018326 | Nevi and Melanomas |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Non-invasive adhesive biopsies of suspicious skin lesions.
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