DERM Health Economics Study
- Conditions
- MelanomaNon-melanoma Skin Cancer
- Interventions
- Device: Deep Ensemble for the Recognition of Malignancy (DERM)
- Registration Number
- NCT04123678
- Lead Sponsor
- Skin Analytics Limited
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 700
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description All Deep Ensemble for the Recognition of Malignancy (DERM) Patients attending a Medical Photography facility with at least 1 suspicious skin lesion will be approached to participate in the study. Participants will have an additional macro and dermoscopic image of each suspicious skin lesions suitable for photography. Photographs will be taken by a healthcare professional using an iPhone XR smart phone camera with a DL1 dermoscopic lens attachment. The images will be encrypted and electronically transmitted to Skin Analytics' cloud servers for analysis by DERM. The suspected diagnosis determined by DERM will be compared with dermatologist review and histologically confirmed diagnosis, where obtained. Healthcare resource utilization information and patient satisfaction data will also be collected
- Primary Outcome Measures
Name Time Method Referral rate Study completion, on average 5 days 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
- Secondary Outcome Measures
Name Time Method Number needed to biopsy by teledermatologists on biopsied lesions Study completion, on average 5 days Number needed to biopsy by teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Sensitivity of DERM on biopsied lesions Study completion, on average 5 days Sensitivity of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Specificity of DERM on biopsied lesions Study completion, on average 5 days Specificity of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
False positive rate of DERM on biopsied lesions Study completion, on average 5 days False positive rate of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Positive predictive value of DERM on biopsied lesions Study completion, on average 5 days Positive predictive value of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Specificity of DERM to identify benign conditions Study completion, on average 5 days Specificity of DERM to identify benign conditions, using clinical diagnosis as gold-standard
Positive predictive value of DERM to identify benign conditions Study completion, on average 5 days Positive predictive of DERM to identify benign conditions, using clinical diagnosis as gold-standard
Number needed to biopsy by DERM on biopsied lesions Study completion, on average 5 days Number needed to biopsy by DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Sensitivity of teledermatologists on biopsied lesions Study completion, on average 5 days Sensitivity of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Specificity of teledermatologists on biopsied lesions Study completion, on average 5 days Specificity of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
False negative rate of teledermatologists on biopsied lesions Study completion, on average 5 days False negative rate of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Positive predictive value of teledermatologists on biopsied lesions Study completion, on average 5 days Positive predictive value of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Sensitivity of DERM to identify benign conditions Study completion, on average 5 days Sensitivity of DERM to identify benign conditions, using clinical diagnosis as gold-standard
False negative rate of DERM on biopsied lesions Study completion, on average 5 days False negative rate of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
False positive rate of teledermatologists on biopsied lesions Study completion, on average 5 days False positive rate of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Negative predictive value of teledermatologists on biopsied lesions Study completion, on average 5 days Negative predictive value of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Concordance of DERM result with clinical diagnosis Study completion, on average 5 days Concordance of DERM result with clinical diagnosis
Estimated cost impact associated with introducing DERM into the patient pathway Study completion, on average 5 days 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
False positive rate of DERM to identify benign conditions Study completion, on average 5 days False positive of DERM to identify benign conditions, using clinical diagnosis as gold-standard
False negative rate of DERM to identify benign conditions Study completion, on average 5 days False negative rate of DERM to identify benign conditions, using clinical diagnosis as gold-standard
Percent of patients attending teledermatology by referral route Study completion, on average 5 days Percentage of patients referred to teledermatology through 2-week wait referral, general referral, direct to teledermatology, routine follow-up (etc) referral routes
Time taken from general practitioner (GP) referral to diagnosis Study completion, on average 5 days Time taken (days) from GP referral to either histopathology-confirmed or clinical diagnosis
Negative predictive value of DERM to identify benign conditions Study completion, on average 5 days Negative predictive value of DERM to identify benign conditions, using clinical diagnosis as gold-standard
Number needed to refer by DERM to identify benign conditions Study completion, on average 5 days Number needed to refer by DERM to identify benign conditions, using clinical diagnosis as gold-standard
Proportion of images submitted to DERM that cannot be analysed Study completion, on average 5 days Proportion of images submitted to DERM that cannot be analysed
Patient satisfaction survey Study completion, on average 5 days 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
Trial Locations
- Locations (1)
Chelsea and Westminster Hospital
🇬🇧London, United Kingdom