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| ID | Type | Description | Link |
|---|---|---|---|
| CPC-11033-L | Other Identifier | OHSU Knight Cancer Institute |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pigmented Lesion | Patients identified as having a concerning pigmented lesion and the physician believes it is appropriate to biopsy to rule out melanoma. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VivaScope System | Device | VivaScope System, Model#s 1500 and 2500 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of confocal microscope to improve melanoma detection | Determine the sensitivity of confocal microscopy in the diagnosis of melanoma by comparison to the gold standard histopathologic diagnosis. | Up to 1 year |
| Specificity of the confocal microscope to improve melanoma detection | Determine the specificity of confocal microscopy in the diagnosis of melanoma by comparison to the gold standard histopathologic diagnosis | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Patterns seen on the confocal image | 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 | Up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Eric Simpson | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| 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 |