Clinical evaluation of the Arclight dermatoscope attachment for primary care skin cancer triage: a prospective diagnostic accuracy study comparing gold-standard dermatoscopes and Arclight dermatoscope assessments in adults referred to NHS Fife dermatology clinics (Arclight CADET study)
Assessment of skin lesions in adults attending dermatology clinics for specialist evaluation.
Participants attending NHS Fife dermatology clinics with skin lesions requiring assessment will be invited to take part. Following informed consent, participants will undergo dermoscopic examination using both the investigational device (Arclight Dermatoscope attachment) and a standard dermatoscope used in routine clinical practice. The order of device use will be randomised, and clinicians will record whether an intervention is required and their confidence in the decision. Dermoscopic images will also be captured using the Arclight Dermatoscope attachment and a smartphone imaging system. Comparator images will be captured using a DermLite DL1 dermatoscope and smartphone imaging system. Anonymised and randomised image sets will subsequently be reviewed by dermatology clinicians blinded to the device used to acquire the images. All participants will undergo the same study procedures. No additional treatment will be administered, and clinical management will continue according to routine dermatology practice.
1. Adults aged 18 years or older 2. Referred to NHS Fife dermatology clinics for assessment of suspicious skin lesions through standard NHS referral pathways 3. Capable of providing written informed consent prior to any study procedures 4. Able and willing to comply with study procedures, including dermoscopic examination and dermoscopic imaging
1. Inability to provide informed consent, e.g. due to cognitive impairment or language barriers without suitable interpreter support 2. Children or young people (<18 years), as the present study is designed for adult referral pathways 3. Lesions deemed clinically inappropriate for dermoscopic examination by the attending dermatologist