Melanoma (Skin), Nevus, Pigmented Skin
Conditions
Keywords
Pigmented Lesion Assay (PLA), DermTech
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.
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.
Interventions
None listed
Sponsors
DermTech
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Up to 1000 samples will be compared for gene expression analysis results compared to biopsy findings. | 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 | 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 |
Countries
United States
Outcome results
None listed