Clinical trial · Interventional
Genetic Risk Stratification of Pediatric Skin Lesions
NCT05418959CI-TRIAL-00112268enrolling by invitationPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nevus | Nevus | ONTOLOGY_EXACT | 0.98 |
| Skin Lesion | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DermTech PLA noninvasive adhesive biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DermTech PLA noninvasive adhesive biopsy
- description
- Prior to surgical biopsy, a DermTech PLA noninvasive adhesive will be pressed over the lesion to collect superficial skin cells.
- interventionNames
- Diagnostic Test: DermTech PLA noninvasive adhesive biopsy
Primary outcomes (2)
- measure
- Presence or absence of PRAME genetic marker.
- timeFrame
- 1 day
- description
- Presence or absence of PRAME genetic marker from PLA test
- measure
- Presence or absence of LINC genetic marker.
- timeFrame
- 1 da7
- description
- Presence or absence of LINC genetic marker from PLA test
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 20 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDJansen, 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
- BACKGROUNDBrouha 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