Genetic Risk Stratification of Pediatric Skin Lesions

NCT05418959 | Unknown Phase 1

• 1 other identifier: 2022P001412
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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 lesions in children correlates with histopathological diagnosis.

Conditions

Skin Lesion; Nevus

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  1 day

Study Arms (1)

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.

Diagnostic Test: DermTech PLA noninvasive adhesive biopsy

Interventions

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.

DermTech PLA noninvasive adhesive biopsy

Eligibility Criteria

• Age: 0 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Related Publications (2)

• 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

  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.

  PMID: 32550693 BACKGROUND

MeSH Terms

Conditions

Nevus

Condition Hierarchy (Ancestors)

Nevi and Melanomas; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Elena B Hawryluk, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena B Hawryluk, MD, PhD

CONTACT

617-726-5066; ehawryluk@partners.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Non-invasive adhesive biopsies of suspicious skin lesions.

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 14, 2022
• Study Start: September 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share