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| Name | Class |
|---|---|
| University Hospital Heidelberg | OTHER |
| Charite University, Berlin, Germany | OTHER |
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All patients will undergo dermoscopic diagnosis and be documented with a video image storing. The diagnosis based on dermoscopy will be immediately documented. Then, as a second diagnostic procedure, fluorescence diagnostics based on the two photon excitation from a dye-laser will be performed. The classification as non-melanoma or malignant melanoma by the medical device LIMES will also be documented immediately. Afterwards, the lesion will be excised and undergo histopathologic examination by the respective histopathologist of the participating centers. The histopathologic diagnosis will serve as gold standard for subsequent evaluations of the diagnostic accuracy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mole | Patients with suspicious moles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIMES | Device | All patients will undergo dermoscopic diagnosis and be documented with a video image storing. The diagnosis based on dermoscopy will be immediately documented. Then, as a second diagnostic procedure, fluorescence diagnostics based on the two photon excitation from a dye-laser will be performed. The classification as non-melanoma or malignant melanoma by the medical device LIMES will also be documented immediately. Afterwards, the lesion will be excised and undergo histo-pathologic examination by the respective histopathologist of the participating centers. The histopathologic diagnosis will serve as gold standard for subsequent evaluations of the diagnostic accuracy. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine sensitivity and specificity of the algorithm for the fluorescence diagnostics of melanoma. | The comparator and gold standard for the diagnosis will be the histopathological diagnosis of the pigmented lesions. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| To collect data for training and optimization of the diagnostic algorithm. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety of the device and to assess the incidence of adverse events | 7 days |
Inclusion Criteria:
Exclusion Criteria:
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This study evaluates patients with pigmented lesions, which are excised in order to exclude or diagnose cutaneous melanoma.
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| Name | Affiliation | Role |
|---|---|---|
| Claus Garbe, MD | Dept. of Dermatology, University Hospital Tübingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Dermatology, Charité | Berlin | 10117 | Germany | |||
| Dept. of Dermatology, University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32657017 | Derived | Hofmann MA, Keim U, Jagoda A, Forschner A, Fink C, Spankuch I, Tampouri I, Eigentler T, Weide B, Haenssle HA, Garbe C. Dermatofluoroscopy diagnostics in different pigmented skin lesions: Strengths and weaknesses. J Dtsch Dermatol Ges. 2020 Jul;18(7):682-690. doi: 10.1111/ddg.14163. Epub 2020 Jul 12. | |
| 27993903 | Derived |
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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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| Heidelberg |
| 69120 |
| Germany |
| Dept. of Dermatology, University Hospital | Tübingen | 72076 | Germany |
| Fink C, Hofmann M, Jagoda A, Spaenkuch I, Forschner A, Tampouri I, Lomberg D, Leupold D, Garbe C, Haenssle HA. Study protocol for a prospective, non-controlled, multicentre clinical study to evaluate the diagnostic accuracy of a stepwise two-photon excited melanin fluorescence in pigmented lesions suspicious for melanoma (FLIMMA study). BMJ Open. 2016 Dec 19;6(12):e012730. doi: 10.1136/bmjopen-2016-012730. |
| 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 |