Genetic Risk Stratification of Pediatric Skin Lesions

NCT ID: NCT05418959

Last Updated: 2022-06-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-01-01

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.

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.

Conditions

Skin Lesion; Nevus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

DermTech PLA noninvasive adhesive biopsy

Prior to surgical biopsy, a DermTech PLA noninvasive adhesive will be pressed over the lesion to collect superficial skin cells.

Group Type: EXPERIMENTAL

DermTech PLA noninvasive adhesive biopsy

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Elena Hawryluk

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elena B Hawryluk, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Central Contacts

Elena B Hawryluk, MD, PhD

Role: CONTACT

ehawryluk@partners.org

617-726-5066

References

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 32550693 (View on PubMed)

Other Identifiers

2022P001412

Identifier Type: -

Identifier Source: org_study_id