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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.
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.
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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This study will enroll all patients who present to a physician for examination of lesions suspicsion for melanoma
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| Name | Affiliation | Role |
|---|---|---|
| James Rock | DermTech | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatologic Surgery Center | Chevy Chase | Maryland | 20185 | United States | ||
| University of Utah Huntsman Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27505074 | Result | 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. | |
| 27707590 | 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. |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D010859 | Pigmentation Disorders |
| D009506 | Nevus |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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Skin issue collected non-invasively will the extracted and nucleic acids isolated.
| Salt Lake City |
| Utah |
| 84112 |
| United States |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |