How Consistent is the Output of DERM, When Used to Assess Images of Potentially Cancerous Skin Lesions.

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How Consistent is the Output of DERM, When Used to Assess Images of Potentially Cancerous Skin Lesions.

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06654999
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Skin Analytics Limited
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries	United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Skin Cancer, Melanoma of Skin, Squamous Cell Cancer, Basal Cell Cancer

Arms & Interventions

Arms

: All patients

All patients will have their skin lesion imaged in the same way

Interventions

Device: - Deep Ensemble for the Recognition of Malignancy (DERM)

DERM variants "+" and "DS"

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.