Basal Cell Cancer, Melanoma of Skin, Skin Cancer, Squamous Cell Cancer
Conditions
Keywords
Precision, DERM, Repeatability, Reproducability
Brief summary
DERM is a Medical Device that uses artificial intelligence to help doctors check if a skin lesion might be cancerous. It works by analysing close-up pictures of skin lesions taken with a smartphone. This study aims to demonstrate how consistent (precise) the output of DERM is: i.e. does it provide the same result when it analyses multiple photos of the same lesion (repeatability), and when the same lesion is photographed by different people, or with different cameras (reproducibility). Adults with at least one skin lesion that doctors are checking for cancer, as part of their standard care, will be able to take part. Suitable lesions will be photographed three times, each by three different people using three sets of image capture hardware (specifically, an iPhone 11 with a DL200/HR dermoscopic lens). Each image will be checked for good image quality as it is captured. Images will then be transferred to DERM, where they'll be analysed. The DERM output won't be shared with the patients or doctors involved in the study. The patients will continue to have their skin lesion biopsy/excised, in accordance with standard of care. Their diagnosis will be collected and compared to the output from DERM.
Interventions
DERM variants + and DS
Sponsors
Skin Analytics Limited
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or Female, * aged 18 years or above, * Willing and able to give informed consent for participation in the study, * Has at least one skin lesion that, following assessment by a primary care provider and a dermatology specialist, will be biopsied due to a high suspicion of skin cancer, and is suitable for assessment by DERM. * In the Investigator's opinion, able and willing to comply with all study requirements.
Exclusion criteria
* Patients with more than one skin lesion due for biopsy * 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. To be suitable for inclusion, a skin lesion must NOT have ANY of the following limitations: * Be located on an anatomical site of different skin structure: palms of hands or soles of feet (acral lesion), mucosal surfaces (lips and eyes) or under nail (ungal lesion), * Have a diameter greater than the diameter of the dermoscopic lens, * Be located on an anatomical site unsuitable for photographing, including on surface of genitals and hair-bearing areas, * Have been previously biopsied, excised, treated or is otherwise traumatised * Be located in an area of visible scarring or tattooing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reproducibility: Average Positive Agreement (APA) of DERM on malignant lesions is >80% | 1 day | Each lesion will be imaged by three users using three sets of the image capture hardware, generating nine data sets (user/hardware combinations) per lesion. Each lesion image data set will consist of 3 repeated measures, resulting in 27 measures per lesion |
| Repeatability: Average Positive Agreement (APA) of DERM on malignant lesions is >80% | 1 day | Each lesion will be imaged by three users using three sets of the image capture hardware, generating nine data sets (user/hardware combinations) per lesion. Each lesion image data set will consist of 3 repeated measures, resulting in 27 measures per lesion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reproducibility: Average Negative Agreement (ANA) of DERM on benign lesions is >50% | 1 day | Each lesion will be imaged by three users using three sets of the image capture hardware, generating nine data sets (user/hardware combinations) per lesion. Each lesion image data set will consist of 3 repeated measures, resulting in 27 measures per lesion. |
| Repeatability: Average Negative Agreement (ANA) of DERM on benign lesions is >50% | 1 day | Each lesion will be imaged by three users using three sets of the image capture hardware, generating nine data sets (user/hardware combinations) per lesion. Each lesion image data set will consist of 3 repeated measures, resulting in 27 measures per lesion. |
Countries
United Kingdom
Outcome results
None listed