DERM Health Economics Study

Melanoma Clinical Trial

Official title:

Impact of an Artificial Intelligence Platform (DERM) on the Healthcare Resource Utilisation (HRU) Needed to Diagnose Skin Cancer When Used as Part of a United Kingdom-based Teledermatology Service

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04123678
• Other study ID #: DERM-005
• Status: Completed
• Start date: February 26, 2020
• Est. completion date: August 6, 2021

Study information

• Verified date: August 2021
• Source: Skin Analytics Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to provide an initial assessment of the potential impact DERM could have on the number of onward referrals for a face to face dermatologist review and/or biopsy from a teledermatology-based service, and to improve the understanding of the patient pathways that exist.

Description:

DERM, an Artificial Intelligence (AI)-based diagnosis support tool, has been shown to be able to accurately identify melanoma, non-melanoma skin cancers (NMSC) and other conditions from historical images of suspicious skin lesions (moles).

This study aims to establish whether the use of DERM in the patient pathway could reduce the number of unnecessary referrals to dermatologist review and/or biopsy.

Suspicious skin lesions that are due to be photographed for a dermatologist to review, will have two additional photographs taken using a commonly available smart phone camera with and without a specific lens attachment. The images will be analysed by DERM, and the results compared to the clinician's diagnosis (all lesions) and histologically-confirmed diagnosis (any lesion that is biopsied).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: August 6, 2021
• Est. primary completion date: August 5, 2021
• 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,

• Has at least one suspicious skin lesion which is being photographed as part of Standard of Care (SoC),

• In the Investigators 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 participants 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

• Melanoma
• Non-melanoma Skin Cancer
• Skin Neoplasms

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Chelsea and Westminster Hospital	London

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
Primary	Referral rate	The rate of unnecessary referrals for a face to face dermatologist review for the same detection rate between standard of care and DERM of lesions reviewed by teledermatology or DERM	Study completion, on average 5 days
Secondary	Sensitivity of DERM on biopsied lesions	Sensitivity of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard	Study completion, on average 5 days
Secondary	Specificity of DERM on biopsied lesions	Specificity of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard	Study completion, on average 5 days
Secondary	False positive rate of DERM on biopsied lesions	False positive rate of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard	Study completion, on average 5 days
Secondary	False negative rate of DERM on biopsied lesions	False negative rate of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard	Study completion, on average 5 days
Secondary	Positive predictive value of DERM on biopsied lesions	Positive predictive value of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard	Study completion, on average 5 days
Secondary	Number needed to biopsy by DERM on biopsied lesions	Number needed to biopsy by DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard	Study completion, on average 5 days
Secondary	Sensitivity of teledermatologists on biopsied lesions	Sensitivity of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard	Study completion, on average 5 days
Secondary	Specificity of teledermatologists on biopsied lesions	Specificity of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard	Study completion, on average 5 days
Secondary	False positive rate of teledermatologists on biopsied lesions	False positive rate of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard	Study completion, on average 5 days
Secondary	False negative rate of teledermatologists on biopsied lesions	False negative rate of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard	Study completion, on average 5 days
Secondary	Positive predictive value of teledermatologists on biopsied lesions	Positive predictive value of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard	Study completion, on average 5 days
Secondary	Negative predictive value of teledermatologists on biopsied lesions	Negative predictive value of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard	Study completion, on average 5 days
Secondary	Number needed to biopsy by teledermatologists on biopsied lesions	Number needed to biopsy by teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard	Study completion, on average 5 days
Secondary	Sensitivity of DERM to identify benign conditions	Sensitivity of DERM to identify benign conditions, using clinical diagnosis as gold-standard	Study completion, on average 5 days
Secondary	Specificity of DERM to identify benign conditions	Specificity of DERM to identify benign conditions, using clinical diagnosis as gold-standard	Study completion, on average 5 days
Secondary	False positive rate of DERM to identify benign conditions	False positive of DERM to identify benign conditions, using clinical diagnosis as gold-standard	Study completion, on average 5 days
Secondary	False negative rate of DERM to identify benign conditions	False negative rate of DERM to identify benign conditions, using clinical diagnosis as gold-standard	Study completion, on average 5 days
Secondary	Positive predictive value of DERM to identify benign conditions	Positive predictive of DERM to identify benign conditions, using clinical diagnosis as gold-standard	Study completion, on average 5 days
Secondary	Negative predictive value of DERM to identify benign conditions	Negative predictive value of DERM to identify benign conditions, using clinical diagnosis as gold-standard	Study completion, on average 5 days
Secondary	Number needed to refer by DERM to identify benign conditions	Number needed to refer by DERM to identify benign conditions, using clinical diagnosis as gold-standard	Study completion, on average 5 days
Secondary	Concordance of DERM result with clinical diagnosis	Concordance of DERM result with clinical diagnosis	Study completion, on average 5 days
Secondary	Percent of patients attending teledermatology by referral route	Percentage of patients referred to teledermatology through 2-week wait referral, general referral, direct to teledermatology, routine follow-up (etc) referral routes	Study completion, on average 5 days
Secondary	Time taken from general practitioner (GP) referral to diagnosis	Time taken (days) from GP referral to either histopathology-confirmed or clinical diagnosis	Study completion, on average 5 days
Secondary	Estimated cost impact associated with introducing DERM into the patient pathway	The cost of the number of referrals for face to face dermatologist review and/or biopsy that would have been saved / charged if DERM had been used to decide whether to refer the patient onwards	Study completion, on average 5 days
Secondary	Proportion of images submitted to DERM that cannot be analysed	Proportion of images submitted to DERM that cannot be analysed	Study completion, on average 5 days
Secondary	Patient satisfaction survey	Patient feedback on their experience of the service. Patients will rate whether they agree, or don't agree, with statements that assess their acceptance of having a computer involved in their diagnosis pathway	Study completion, on average 5 days