Genetic Risk Stratification of Pediatric Skin Lesions

Skin Lesion Clinical Trial

Official title:

Genetic Risk Stratification of Pediatric Skin Lesions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05418959
• Other study ID #: 2022P001412
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: September 1, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: June 2022
• Source: Massachusetts General Hospital
• Contact: Elena B Hawryluk, MD, PhD
• Phone: 617-726-5066
• Email: ehawryluk[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Nevus
• Skin Lesion

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

References & Publications (2)

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or absence of PRAME genetic marker.	Presence or absence of PRAME genetic marker from PLA test	1 day
Primary	Presence or absence of LINC genetic marker.	Presence or absence of LINC genetic marker from PLA test	1 da7
Secondary	Incidence of Treatment-Emergent Adverse Events	No. of adverse events from adhesive skin biopsy.	1 day