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This is a prospective study to assess efficacy of the Nevisense device in identifying keratinocyte skin cancer (KC) in patients suspected of having skin cancer based on the initial physician's assessment.
All skin lesions with a suspicion of Basal cell carcinoma (BCC), Invasive Squamos cell Carcinoma (iSCC), Bowen's disease (BD) or actinic keratosis (AK) and destined for excision or biopsy for further histopathological analysis will be considered for inclusion in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nevisense | Other | This will be a prospective investigator-initiated study to evaluate the accuracy of Nevisense for KC. First evaluation steps include dermatologist's clinical examination (visual inspection) and videodermoscopy. In those cases where the routine diagnostic procedures given above identify any suspicion of a KC, a Nevisense measurement is to be conducted after examination of inclusion and exclusion criteria. Thereafter, surgical excision and histopathologic examination follow. All skin lesions with a suspicion of BCC, iSCC, BD or AK and destined for excision or biopsy for further histopathological analysis will be considered for inclusion in the study. A maximum of three lesions per patient will be allowed for the study. The study aims to enrol 250 lesions in total. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nevisense | Device | The Nevisense system is based on Electrical Impedance Spectroscopy (EIS). EIS is a measure of the overall resistance within a skin tissue, at alternating currents of various frequencies. Since skin tissues have different electrical properties depending on cell structure and medical conditions, the resulting electrical impedance spectra will reflect the properties of the skin tissue. |
| Measure | Description | Time Frame |
|---|---|---|
| Nevisense Sensitivity and Specificity | This study has two primary endpoints:
Sensitivity is the proportion of correctly identified cases of KC. Specificity is the proportion of correctly identified cases of non-KC | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Per Svedenhag | Contact | +46 8410 620 01 | per.svedenhag@scibase.com |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Dirschka, Prof. Dr. med. | CentroDerm GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CentroDerm | Recruiting | Wuppertal | Germany |
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