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

NCT ID: NCT06654999

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 115 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-18
• Study Completion Date: 2025-06-30

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.

Conditions

Skin Cancer; Melanoma of Skin; Squamous Cell Cancer; Basal Cell Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

All patients

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

Deep Ensemble for the Recognition of Malignancy (DERM)

Intervention Type: DEVICE

DERM variants "+" and "DS"

Interventions

Deep Ensemble for the Recognition of Malignancy (DERM)

DERM variants "+" and "DS"

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Skin Analytics Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Norwich and Norfolk Hospitals Trust

Norwich, , United Kingdom

University Hospitals Dorset

Poole, , United Kingdom

Surrey and Sussex Hospital Trust

Redhill, , United Kingdom

Countries

United Kingdom

Other Identifiers

DERM-011

Identifier Type: -

Identifier Source: org_study_id