Keratinocyte Skin Cancer Clinical Trial
Official title:
Evaluation of the Clinical Utility of a New Diagnostic Support Tool, Based on Electrical Impedance Spectroscopy (NEVISENSE), for Keratinocyte Skin Cancer
NCT number | NCT06064019 |
Other study ID # | EIS-KC001 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 13, 2023 |
Est. completion date | September 2024 |
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All male or female patients of any ethnicity, = 18 years with skin lesions of a clinical uncertain diagnosis suspicious for KC (such as BCC, iSCC, BD or AK) Exclusion Criteria: - Metastases of recurrent lesions - Lesion located on acral skin, e.g. sole or palm - Lesion located on areas of scars, crusts, psoriasis or similar skin conditions - Lesion on hair-covered areas, e.g. scalp, beards, moustaches - Lesion located on genitalia - Lesion located in an area that has been previously biopsied or subjected to any kind of surgical intervention or traumatized - Lesion located on mucosal surfaces - Lesion with foreign matter, e.g. tattoo or splinter - Lesion and / or reference located on acute sunburn - Skin surface not measurable, e.g. lesion on a stalk - Skin surface not accessible, e.g. inside ears, under nails |
Country | Name | City | State |
---|---|---|---|
Germany | CentroDerm | Wuppertal |
Lead Sponsor | Collaborator |
---|---|
SciBase AB |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nevisense Sensitivity and Specificity | This study has two primary endpoints:
Sensitivity = 0.90 Sensitivity + Specificity > 1.0 Sensitivity is the proportion of correctly identified cases of KC. Specificity is the proportion of correctly identified cases of non-KC |
1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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