Clinical trial NCT06654999: How Consistent is the Output of DERM, When Used to Assess Images of Potentially Cancerous Skin Lesions.
Official title: A Precision Study To Demonstrate The Repeatability and Reproducability of DERM Outputs
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Skin Cancer
Melanoma of Skin
Squamous Cell Cancer
Basal Cell Cancer
Keywords: Precision
DERM
Repeatability
Reproducability
Lead sponsor: Skin Analytics Limited
Sponsor class: INDUSTRY
First posted: 2024-10-23
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited in specialist dermatology clinics in the UK.

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.


Eligibility 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.

Primary outcomes:
measure: Reproducibility: Average Positive Agreement (APA) of DERM on malignant lesions is >80%
timeFrame: 1 day
measure: Repeatability: Average Positive Agreement (APA) of DERM on malignant lesions is >80%
timeFrame: 1 day
Secondary outcomes:
measure: Reproducibility: Average Negative Agreement (ANA) of DERM on benign lesions is >50%
timeFrame: 1 day
measure: Repeatability: Average Negative Agreement (ANA) of DERM on benign lesions is >50%
timeFrame: 1 day
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Norwich and Norfolk Hospitals Trust
city: Poole
country: United Kingdom
facility: University Hospitals Dorset
city: Redhill
country: United Kingdom
facility: Surrey and Sussex Hospital Trust
Study officials:
References: