Evaluation of Nevisense as Support Tool for the Diagnose of Keratinocyte Skin Cancer

SciBase

Status: Enrolling

Conditions: Keratinocyte Skin Cancer

Treatments: Device: Nevisense

Study type: Interventional

Funder types: Other

Identifiers

NCT06064019

EIS-KC001

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Nevisense

Other group

Description:

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.

Treatment:

Device: Nevisense