An observational study in Skin Cancer, Melanoma of Skin and Squamous Cell Cancer, sponsored by Skin Analytics Limited. Completed at 3 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-09.
Sponsored by Skin Analytics Limited · Observational
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.
3,370 studies on the registry are indexed under Melanoma; 578 are open to participants now.
This study's enrollment of 115 is below the median of 187 across 488 observational studies indexed under Melanoma.
Browse Melanoma studies →Skin Analytics Limited is the lead sponsor of 5 studies on the registry; none are open to participants now.
Compared within Melanoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Skin Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients will be recruited in specialist dermatology clinics in the UK.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
To be suitable for inclusion, a skin lesion must NOT have ANY of the following limitations:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients will have their skin lesion imaged in the same way
Device: Deep Ensemble for the Recognition of Malignancy (DERM)
DERM variants "+" and "DS"
Reproducibility: Average Positive Agreement (APA) of DERM on malignant lesions is >80%
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
Time frame: 1 day
Repeatability: Average Positive Agreement (APA) of DERM on malignant lesions is >80%
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.
Time frame: 1 day
Reproducibility: Average Negative Agreement (ANA) of DERM on benign lesions is >50%
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.
Time frame: 1 day
Repeatability: Average Negative Agreement (ANA) of DERM on benign lesions is >50%
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.
Time frame: 1 day
Plan to share: Undecided — Subject to constraints in patient consent
No publications or documents are linked to this record.
Ran from Dec 2024 to primary completion in Jun 2025, 6 months.
Of 59 industry-sponsored observational studies under Melanoma, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 80. This study's 6 months is below that.
Counting every sponsor, half of 236 studies reached it within 71 months; a quarter within 35 and three quarters within 223.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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