Sample Collection Study in Patients With Suspected Melanoma Utilizing DermTech's Non-invasive Adhesive Patch Biopsy Kits

A Multi-center Sample Collection Study in Patients With Suspected Melanoma Utilizing DermTech's Non-invasive Adhesive Patch Biopsy Kits

A multi-center sample collection study in patients presenting with pigmented lesion(s) suspicious for melanoma. All suspicious lesions should meet at least one of the "ABCDE" criteria.

Study Overview

• Status: Completed
• Conditions: Nevus; Melanoma (Skin); Pigmented Skin

Detailed Description

A multi-center sample collection study in patients presenting with pigmented lesion(s) suspicious for melanoma. All suspicious lesions should meet at least one of the "ABCDE" (asymmetry, border, color, diameter, evolving) criteria. Patients will be consented for the study and screened against the inclusion and exclusion criteria. Once the patient is determined to be acceptable for the study they will be assigned a unique patient number and tissue collection will begin. Tissue from the lesion will be collected using DermTech's non-invasive adhesive patch kit according to the instructions for use followed by surgical biopsy. Digital dermoscopy of the lesion is preferred but not required.

• Study Type: Observational
• Enrollment (Actual): 652

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Chevy Chase, Maryland, United States, 20185
      • Dermatologic Surgery Center
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah Huntsman Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study will enroll all patients who present to a physician for examination of lesions suspicsion for melanoma

Description

Inclusion Criteria:

1. Males and females at least 21 years of age
2. Have a pigmented lesion suspicious for melanoma the pigmented lesion meets at least one of the "ABCDE" criteria
3. The pigmented lesion mst be at least 3mm and not more than 16mm in diameter
4. Patient is willing to follow the start of care to test and treat the pigmented lesion as determined by the treating physician
5. Willing to have DermTech adhesive patch biopsies performed
6. Must be able to complete study procedures as required by the protocol
7. Willing to provide informed consent to participate in this trial

Exclusion Criteria:

1. Require a surgical biopsy or excision of the lesion of interest prior to the DermTech non-invasive patch biopsy(ies)
2. Has an ulcerated or bleeding lesion that could confound the biopsy results
3. Has a suspicious lesion(s) in an area that was previously surgically biopsied
4. Has a lesion that is classified as "clinically" evident melanoma appropriate for excision
5. The lesion to be sampled is on the mucosal surface, palmoplantar surface or other area where adhesive patch biopsies cannot be performed
6. Has a known sensitivity to adhesive patches
7. Any significant medical condition that would indicate an unreasonable risk to the patient or potential interference with the study
8. Lesion is in a location were sufficient removal of non-vellus hair cannot be achieved (e.g., scalp)
9. Suspected non-melanoma skin cancer
10. Patients with contraindication(s) to surgical biopsy -

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Up to 1000 samples will be compared for gene expression analysis results compared to biopsy findings.	gene expression associated with melanoma vs non-melanoma compared to surgical biopsy	Samples will be extracted and analyzed once up to 1000 samples have been collected and compared to surgical biopsy reports. Analysis results are expected in 2021
Up to 1000 samples will be compared to biopsy results for DNA mutations	Dna mutations associated with more aggressive forms of melanoma	Samples will be extracted and analyzed once up to 1000 samples have been collected and compared to surgical reports and DNA mutation analysis. Analysis results are expected in 2021

Collaborators and Investigators

• Sponsor: DermTech

Publications and helpful links

General Publications

• Yao Z, Allen T, Oakley M, Samons C, Garrison D, Jansen B. Analytical Characteristics of a Noninvasive Gene Expression Assay for Pigmented Skin Lesions. Assay Drug Dev Technol. 2016 Aug;14(6):355-63. doi: 10.1089/adt.2016.724.
• Gerami P, Yao Z, Polsky D, Jansen B, Busam K, Ho J, Martini M, Ferris LK. Development and validation of a noninvasive 2-gene molecular assay for cutaneous melanoma. J Am Acad Dermatol. 2017 Jan;76(1):114-120.e2. doi: 10.1016/j.jaad.2016.07.038. Epub 2016 Oct 1.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ACTUAL): July 15, 2022
• Study Completion (ACTUAL): July 15, 2022

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (ACTUAL): September 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Pigmented Lesion Assay (PLA); DermTech
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Pigmentation Disorders
• Other Study ID Numbers: 19-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No