Melanoma, Non-melanoma Skin Cancer
Conditions
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).
Interventions
AI-based decision support tool
Sponsors
Innovate UK
Skin Analytics Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 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 |
| 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 |
| 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 |
| 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 to identify benign conditions | Study completion, on average 5 days | Specificity of DERM to identify benign conditions, using clinical diagnosis as gold-standard |
| 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 |
| 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 |
| 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 |
| Concordance of DERM result with clinical diagnosis | Study completion, on average 5 days | Concordance of DERM result with clinical diagnosis |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
United Kingdom
Outcome results
None listed