DERM NMSC Validation Study

Non-melanoma Skin Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04116983
• Other study ID #: DERM-003
• Status: Completed
• Start date: June 26, 2020
• Est. completion date: March 16, 2022

Study information

• Verified date: May 2022
• Source: Skin Analytics Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 572
• Est. completion date: March 16, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Non-melanoma Skin Cancer
• Skin Neoplasms

Intervention

Device:
• Deep Ensemble for the Recognition of Malignancy (DERM)
An AI-based diagnosis support tool

Locations

Country	Name	City	State
United Kingdom	Royal Free London NHS Foundation Trust	London
United Kingdom	Royal Victoria Infirmary	Newcastle Upon Tyne
United Kingdom	Poole General Hospital	Poole

Sponsors (2)

Lead Sponsor	Collaborator
Skin Analytics Limited	Innovate UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact of patient characteristics on the DERM and clinician assessment	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;	Study completion: on average 2 days
Other	Impact of lesion characteristics on the DERM and clinician assessment	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	Study completion: on average 2 days
Other	The impact of image variables on the diagnostic accuracy of DERM assessment	The impact of image variables (such as macro and dermoscopic images) on the diagnostic accuracy of DERM assessment	Study completion: on average 2 days
Other	DERM performance (AUROC) when macro images are used both to train the algorithm and as test images	Exploration of whether macro images can be used as part of DERM's assessment	Study completion: on average 2 days
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Concordance of clinician assessment with histologically confirmed diagnosis	Concordance of clinician assessment with histologically confirmed diagnosis	Study completion: on average 2 days
Secondary	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
Secondary	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
Secondary	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