Clinical trial NCT04116983: DERM NMSC Validation Study
Official title: Effectiveness of an Image Analysing Algorithm (DERM) to Diagnose Non-melanoma Skin Cancer (NMSC) and Benign Skin Lesions Compared to Gold Standard Clinical and Histological Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-melanoma Skin Cancer
Lead sponsor: Skin Analytics Limited
Sponsor class: INDUSTRY
Collaborators: name: Innovate UK
First posted: 2019-10-07
Enrollment: 572
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending a dermatology clinic with at least 1 suspicious skin lesion

Brief summary: This study aims to establish the effectiveness of an Artificial Intelligence (AI) algorithm (DERM) to determine the presence of Basal Cell Carcinoma (BCC) and Squamous Cell Carcinoma (SCC) and frequently observed benign conditions, when used to analyse images of skin lesions taken by commonly available smart phone cameras.

Detailed description: DERM, an Artificial Intelligence (AI)-based diagnosis support tool, has been shown to be able to accurately identify Non-melanoma skin cancers (NMSC) and other conditions from historical images of suspicious skin lesions (moles). This study aims to establish how well DERM determines the presence of these conditions in images of skin lesions collected in a clinical setting.

Suspicious skin lesions that are due to be assessed by a dermatologist and a patch of healthy skin will be photographed using three commonly available smart phone cameras with a specific lens attachment. The images will be analysed by DERM, and the results compared to the clinician's diagnosis (all lesions) and histologically-conformed diagnosis (any lesion that is biopsied).

Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study,
* Male or Female, aged 18 years or above,
* Have at least suspicious skin lesion which is suitable for photographing (\<15mm, not located on an anatomical site inappropriate to photograph (genitalia, hair-bearing areas, under nails), not previously biopsied, not located in an area of visible scarring or tattooing),
* In the Investigator's opinion, able and willing to comply with all study requirements.

Exclusion Criteria:

* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study

Primary outcomes:
measure: AUROC of DERM performance when analysing images of biopsied lesions
timeFrame: Study completion
Secondary outcomes:
measure: AUROC of DERM performance when analysing images of non-biopsied lesions
timeFrame: Study completion: on average 2 days
measure: The sensitivity of DERM when used to assess biopsied lesions
timeFrame: Study completion: on average 2 days
measure: The specificity of DERM when used to assess biopsied lesions
timeFrame: Study completion: on average 2 days
measure: The false positive rate of DERM when used to assess biopsied lesions
timeFrame: Study completion: on average 2 days
measure: The false negative rate of DERM when used to assess biopsied lesions
timeFrame: Study completion: on average 2 days
measure: The positive predictive value of DERM when used to assess biopsied lesions
timeFrame: Study completion: on average 2 days
measure: The negative predictive value of DERM when used to assess biopsied lesions
timeFrame: Study completion: on average 2 days
measure: The sensitivity of DERM when used to assess non-biopsied lesions
timeFrame: Study completion: on average 2 days
measure: The specificity of DERM when used to assess non-biopsied lesions
timeFrame: Study completion: on average 2 days
measure: The false positive rate of DERM when used to assess non-biopsied lesions
timeFrame: Study completion: on average 2 days
measure: The false negative rate of DERM when used to assess non-biopsied lesions
timeFrame: Study completion: on average 2 days
measure: The positive predictive value of DERM when used to assess non-biopsied lesions
timeFrame: Study completion: on average 2 days
measure: The negative predictive value of DERM when used to assess non-biopsied lesions
timeFrame: Study completion: on average 2 days
measure: Concordance of clinician assessment with histologically confirmed diagnosis
timeFrame: Study completion: on average 2 days
measure: The concordance of DERM result generated using images from each camera
timeFrame: Study completion: on average 2 days
measure: The proportion of skin lesions with 3 images that can be analysed by DERM;
timeFrame: Study completion: on average 2 days
measure: The proportion of skin lesions with at least 1 readable image that can be analysed by DERM
timeFrame: Study completion: on average 2 days
Other outcomes:
measure: Impact of patient characteristics on the DERM and clinician assessment
timeFrame: Study completion: on average 2 days
measure: Impact of lesion characteristics on the DERM and clinician assessment
timeFrame: Study completion: on average 2 days
measure: The impact of image variables on the diagnostic accuracy of DERM assessment
timeFrame: Study completion: on average 2 days
measure: DERM performance (AUROC) when macro images are used both to train the algorithm and as test images
timeFrame: Study completion: on average 2 days
Locations:
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
city: Newcastle Upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Poole
country: United Kingdom
facility: Poole General Hospital
Study officials:
References: