DERM NMSC Validation Study

Completed

• Conditions: Non-melanoma Skin Cancer
• Interventions: Device: Deep Ensemble for the Recognition of Malignancy (DERM)

• Registration Number: NCT04116983
• Lead Sponsor: Skin Analytics Limited

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).

Study Timeline

• Study First Submitted: 2019-09-30
• Study First Submitted QC: 2019-10-02
• Study First Posted: 2019-10-07
• Study Start: 2020-06-26
• Primary Completion: 2022-02-28
• Study Completion: 2022-03-16
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 572

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All patients	Deep Ensemble for the Recognition of Malignancy (DERM)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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 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 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 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
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
Concordance of clinician assessment with histologically confirmed diagnosis	Study completion: on average 2 days	Concordance of clinician assessment with histologically confirmed diagnosis
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 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 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
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 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
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;

Trial Locations

Locations (3)

Poole General Hospital; 🇬🇧 Poole, United Kingdom

Royal Victoria Infirmary; 🇬🇧 Newcastle Upon Tyne, United Kingdom

Royal Free London NHS Foundation Trust; 🇬🇧 London, United Kingdom