Melanoma
Conditions
Brief summary
The purpose of this study is to show how well a new device, confocal microscope, works to detect malignant melanoma, a type of skin cancer.
Interventions
DEVICEVivaScope System
VivaScope System, Model#s 1500 and 2500
Sponsors
OHSU Knight Cancer Institute
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 12 or older * Patient who has already been selected by their dermatologist for biopsy of a suspicious pigmented lesion and who consents to participate in the study * Signed informed consent
Exclusion criteria
* Age \< 12 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of confocal microscope to improve melanoma detection | Up to 1 year | Determine the sensitivity of confocal microscopy in the diagnosis of melanoma by comparison to the gold standard histopathologic diagnosis. |
| Specificity of the confocal microscope to improve melanoma detection | Up to 1 year | Determine the specificity of confocal microscopy in the diagnosis of melanoma by comparison to the gold standard histopathologic diagnosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patterns seen on the confocal image | Up to 1 year | Evaluate and confirm patterns seen on the confocal image, which are characteristic of melanoma and atypical nevi: A) Pagetoid melanoma cells: melanocytes in suprabasal areas of the epidermis B) Irregular dermal-epidermal junction |
Countries
United States
Outcome results
None listed