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| Name | Class |
|---|---|
| NHS Lanarkshire | OTHER_GOV |
| NHS Tayside | OTHER_GOV |
| NHS Greater Glasgow and Clyde | OTHER |
| University Hospitals, Leicester |
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The purpose of this study is to establish the clinical utility of the Melanoma Detection System (MDS).
The purpose of this study is to establish the clinical utility of the MDS while continuing to evaluate the safety and performance of the MDS in patients with skin lesions who are referred to secondary care clinics for evaluation, whose lesions (moles) are suspicious for melanoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urgent Excision | Subjects with moles suspicious of melanoma and are scheduled for an urgent excision. |
| |
| Non-urgent Excision | Subjects with moles not-suspicious of melanoma and are scheduled for a non urgent excision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melanoma Detection System -MDS | Diagnostic Test | Imaging of lesion using the MDS test. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Utility of the MDS in determining urgent or non-urgent excision of moles. | The MDS will provide a score that reflects the possibility for the presence of melanoma in moles. The score will be used together with clinical evaluation. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Does the MDS have an additive value to clinical evaluation of moles. | Does the MDS system provide superior results when compared to clinical evaluation. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| User feedback for clinical use of the MDS in the clinical management of moles. | To gain feedback from users on how to best incorporate the MDS testing procedure in the clinical setting. | 1 day |
Inclusion Criteria:
Exclusion Criteria:
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Subjects referred to a specialist for possible presence of melanoma in skin lesions.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHS Lanarkshire, Monklands Hospital | Airdrie | ML60JS | United Kingdom |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| 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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| OTHER |
| University of Dundee | OTHER |
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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 |