Melanoma (DermTech Study)

Study Description

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.

Condition or Disease

Melanoma (Skin)
Pigmented Skin
Nevus

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 Design

Study Type:	Observational
Estimated Enrollment:	1000 participants
Observational Model:	Other
Time Perspective:	Prospective
Official Title:	A Multi-center Sample Collection Study in Patients With Suspected Melanoma Utilizing DermTech’s Non-invasive Adhesive Patch Biopsy Kits
Actual Study Start Date:	March 1, 2019
Estimated Primary Completion Date:	September 15, 2022
Estimated Study Completion Date:	September 30, 2022

Outcome Measures

Primary Outcome Measures

Up to 1000 samples will be compared for gene expression analysis results compared to biopsy findings. [ Time Frame: 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 ]
gene expression associated with melanoma vs non-melanoma compared to surgical biopsy
Up to 1000 samples will be compared to biopsy results for DNA mutations [ Time Frame: 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 ]
Dna mutations associated with more aggressive forms of melanoma

Biospecimen Retention: Samples With DNA

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

Eligibility Criteria

Ages Eligible for Study:	21 Years and older (Adult, Older Adult)
Sexes 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

Inclusion Criteria

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

Exclusion Criteria

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 –

ADDITIONAL DETAILS

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