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

Not Applicable

Recruiting

• Conditions: Keratinocyte Skin Cancer
• Interventions: Device: Nevisense

• Registration Number: NCT06064019
• Lead Sponsor: SciBase AB

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-13
• Study First Submitted: 2023-09-11
• Study First Submitted QC: 2023-09-28
• Study First Posted: 2023-10-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nevisense	Nevisense	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.

Primary Outcome Measures

Name	Time	Method
Nevisense Sensitivity and Specificity	1 year	This study has two primary endpoints: 1. Sensitivity ≥ 0.90; 2. 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

Trial Locations

Locations (1)

CentroDerm; 🇩🇪 Wuppertal, Germany