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

NCT04550000 | Completed

• 1 other identifier: 19-01
• Study Type: observational
• Target: 652
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Melanoma (Skin); Pigmented Skin; Nevus

Keywords

Pigmented Lesion Assay (PLA); DermTech

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• DermTech: lead

Study Sites (2)

Dermatologic Surgery Center

Chevy Chase, Maryland, 20185, United States

Location

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Publications (2)

• 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.

  PMID: 27505074 RESULT

• 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.

  PMID: 27707590 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Skin issue collected non-invasively will the extracted and nucleic acids isolated.

MeSH Terms

Conditions

Melanoma; Pigmentation Disorders; Nevus

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James Rock

  DermTech

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: March 1, 2019
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: October 28, 2022

Record last verified: 2021-03

Locations

US (2)