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

Recruiting now · Not applicable

Conditions studied: Keratinocyte Skin Cancer

In brief

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.

Key facts

Study ID

NCT06064019

Run by

SciBase AB

People needed

150

Starts

2023-07-13

Expected to finish

2025-02-01

Last updated by the study team

2024-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• CentroDerm — Wuppertal, Germany (enrolling)

Full record on ClinicalTrials.gov

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