Clinical trial NCT04123678: DERM Health Economics Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Non-melanoma Skin Cancer
Lead sponsor: Skin Analytics Limited
Sponsor class: INDUSTRY
Collaborators: name: Innovate UK
First posted: 2019-10-11
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients attending Medical Photography for imaging of at least 1 suspicious skin lesion. Patients may have been referred to the teledermatology service or for imaging for monitoring purposes from the dermatology clinic or for virtual teledermatology review.

Brief 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Referral rate
timeFrame: Study completion, on average 5 days
Secondary outcomes:
measure: Sensitivity of DERM on biopsied lesions
timeFrame: Study completion, on average 5 days
measure: Specificity of DERM on biopsied lesions
timeFrame: Study completion, on average 5 days
measure: False positive rate of DERM on biopsied lesions
timeFrame: Study completion, on average 5 days
measure: False negative rate of DERM on biopsied lesions
timeFrame: Study completion, on average 5 days
measure: Positive predictive value of DERM on biopsied lesions
timeFrame: Study completion, on average 5 days
measure: Number needed to biopsy by DERM on biopsied lesions
timeFrame: Study completion, on average 5 days
measure: Sensitivity of teledermatologists on biopsied lesions
timeFrame: Study completion, on average 5 days
measure: Specificity of teledermatologists on biopsied lesions
timeFrame: Study completion, on average 5 days
measure: False positive rate of teledermatologists on biopsied lesions
timeFrame: Study completion, on average 5 days
measure: False negative rate of teledermatologists on biopsied lesions
timeFrame: Study completion, on average 5 days
measure: Positive predictive value of teledermatologists on biopsied lesions
timeFrame: Study completion, on average 5 days
measure: Negative predictive value of teledermatologists on biopsied lesions
timeFrame: Study completion, on average 5 days
measure: Number needed to biopsy by teledermatologists on biopsied lesions
timeFrame: Study completion, on average 5 days
measure: Sensitivity of DERM to identify benign conditions
timeFrame: Study completion, on average 5 days
measure: Specificity of DERM to identify benign conditions
timeFrame: Study completion, on average 5 days
measure: False positive rate of DERM to identify benign conditions
timeFrame: Study completion, on average 5 days
measure: False negative rate of DERM to identify benign conditions
timeFrame: Study completion, on average 5 days
measure: Positive predictive value of DERM to identify benign conditions
timeFrame: Study completion, on average 5 days
measure: Negative predictive value of DERM to identify benign conditions
timeFrame: Study completion, on average 5 days
measure: Number needed to refer by DERM to identify benign conditions
timeFrame: Study completion, on average 5 days
measure: Concordance of DERM result with clinical diagnosis
timeFrame: Study completion, on average 5 days
measure: Percent of patients attending teledermatology by referral route
timeFrame: Study completion, on average 5 days
measure: Time taken from general practitioner (GP) referral to diagnosis
timeFrame: Study completion, on average 5 days
measure: Estimated cost impact associated with introducing DERM into the patient pathway
timeFrame: Study completion, on average 5 days
measure: Proportion of images submitted to DERM that cannot be analysed
timeFrame: Study completion, on average 5 days
measure: Patient satisfaction survey
timeFrame: Study completion, on average 5 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
Study officials:
References: