Non-melanoma Skin Cancer
Conditions
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).
Interventions
An AI-based diagnosis support tool
Sponsors
Innovate UK
Skin Analytics Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUROC of DERM performance when analysing images of biopsied lesions | Study completion | Area Under the Receiver Operating Characteristic Curve (AUROC) of the DERM result of biopsied lesions, using histopathological-confirmed diagnosis as gold standard |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The sensitivity of DERM when used to assess non-biopsied lesions | Study completion: on average 2 days | The sensitivity of DERM when used to assess non-biopsied lesions |
| Concordance of clinician assessment with histologically confirmed diagnosis | Study completion: on average 2 days | Concordance of clinician assessment with histologically confirmed diagnosis |
| The concordance of DERM result generated using images from each camera | Study completion: on average 2 days | The concordance of DERM result generated using images from each camera |
| The proportion of skin lesions with 3 images that can be analysed by DERM; | Study completion: on average 2 days | The proportion of skin lesions with 3 images that can be analysed by DERM; |
| The proportion of skin lesions with at least 1 readable image that can be analysed by DERM | Study completion: on average 2 days | The proportion of skin lesions with at least 1 readable image that can be analysed by DERM |
| AUROC of DERM performance when analysing images of non-biopsied lesions | Study completion: on average 2 days | Area Under the Receiver Operating Characteristic Curve (AUROC) of the DERM result of biopsied lesions, using clinical diagnosis as gold standard |
| The sensitivity of DERM when used to assess biopsied lesions | Study completion: on average 2 days | The sensitivity of DERM when used to assess biopsied lesions |
| The specificity of DERM when used to assess biopsied lesions | Study completion: on average 2 days | The specificity of DERM when used to assess biopsied lesions |
| The false positive rate of DERM when used to assess biopsied lesions | Study completion: on average 2 days | The false positive rate of DERM when used to assess biopsied lesions |
| The false negative rate of DERM when used to assess biopsied lesions | Study completion: on average 2 days | The false negative rate of DERM when used to assess biopsied lesions |
| The positive predictive value of DERM when used to assess biopsied lesions | Study completion: on average 2 days | The positive predictive value of DERM when used to assess biopsied lesions |
| The negative predictive value of DERM when used to assess biopsied lesions | Study completion: on average 2 days | The negative predictive value of DERM when used to assess biopsied lesions |
| The specificity of DERM when used to assess non-biopsied lesions | Study completion: on average 2 days | The specificity of DERM when used to assess non-biopsied lesions |
| The false positive rate of DERM when used to assess non-biopsied lesions | Study completion: on average 2 days | The false positive rate of DERM when used to assess non-biopsied lesions |
| The false negative rate of DERM when used to assess non-biopsied lesions | Study completion: on average 2 days | The false negative rate of DERM when used to assess non-biopsied lesions |
| The positive predictive value of DERM when used to assess non-biopsied lesions | Study completion: on average 2 days | The positive predictive value of DERM when used to assess non-biopsied lesions |
| The negative predictive value of DERM when used to assess non-biopsied lesions | Study completion: on average 2 days | The negative predictive value of DERM when used to assess non-biopsied lesions |
Other
| Measure | Time frame | Description |
|---|---|---|
| The impact of image variables on the diagnostic accuracy of DERM assessment | Study completion: on average 2 days | The impact of image variables (such as macro and dermoscopic images) on the diagnostic accuracy of DERM assessment |
| DERM performance (AUROC) when macro images are used both to train the algorithm and as test images | Study completion: on average 2 days | Exploration of whether macro images can be used as part of DERM's assessment |
| Impact of lesion characteristics on the DERM and clinician assessment | Study completion: on average 2 days | The impact of lesions characteristic (such as growth over last 6 months, stage and sub-type) on the diagnostic accuracy of DERM and clinician assessment |
| Impact of patient characteristics on the DERM and clinician assessment | Study completion: on average 2 days | The impact of patient characteristics (such as sex, age, location of lesion, total body lesion count, Fitzpatrick skin type, past medical history of skin cancer) on the diagnostic accuracy of DERM and clinician assessment; |
Countries
United Kingdom
Outcome results
None listed