DERM NMSC Validation Study

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Non-melanoma Skin Cancer

Intervention / Treatment
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* Device: Deep Ensemble for the Recognition of Malignancy (DERM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All patients<br>Recruited participants will be attending a dermatology clinic with at least one skin lesion where there is a suspicion of skin cancer. All suspicious lesions suitable for photographing will be photographed six times in a single visit. A macro and dermoscopic image of each lesion will be captured by three different mobile phones: an iPhone, a Samsung and a Nokia smart phone, without (macro image) or with (dermoscopic image) a Dermlite DL1 lens attached. Dermoscopic images of healthy skin will also be captured by each camera. Images of the lesions will be analysed by DERM. The DERM results for lesions biopsied will be compared to the biopsy result; the DERM results for lesions not biopsied will be compared to the clinical assessment. | Device: Deep Ensemble for the Recognition of Malignancy (DERM)<br>* An AI-based diagnosis support tool<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUROC of DERM performance when analysing images of biopsied lesions | Area Under the Receiver Operating Characteristic Curve (AUROC) of the DERM result of biopsied lesions, using histopathological-confirmed diagnosis as gold standard | Study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUROC of DERM performance when analysing images of non-biopsied lesions | Area Under the Receiver Operating Characteristic Curve (AUROC) of the DERM result of biopsied lesions, using clinical diagnosis as gold standard | Study completion: on average 2 days | 
| The sensitivity of DERM when used to assess biopsied lesions | The sensitivity 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 specificity 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 positive 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 false negative rate 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 positive 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 negative predictive value of DERM when used to assess biopsied lesions | Study completion: on average 2 days | 
| The sensitivity of DERM when used to assess non-biopsied lesions | The sensitivity 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 specificity 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 positive 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 false negative rate 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 positive 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 | The negative predictive value of DERM when used to assess non-biopsied lesions | Study completion: on average 2 days | 
| Concordance of clinician assessment with histologically confirmed diagnosis | Concordance of clinician assessment with histologically confirmed diagnosis | Study completion: on average 2 days | 
| The concordance of DERM result generated using images from each camera | The concordance of DERM result generated using images from each camera | 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 3 images 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 | The proportion of skin lesions with at least 1 readable image that can be analysed by DERM | Study completion: on average 2 days |