Skip to main content
OpenTrials
Completed

NCT Number: NCT06654999

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Skin Cancer Basal Cell Cancer Melanoma Melanoma of Skin Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Basal Cell Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Squamous Cell Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Squamous Cell Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Norwich and Norfolk Hospitals Trust, Norwich, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deep Ensemble for the Recognition of Malignancy (DERM)

Device

DERM variants "+" and "DS"

Primary outcomes

  1. Reproducibility: Average Positive Agreement (APA) of DERM on malignant lesions is >80%

    Time frame: 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

  2. Repeatability: Average Positive Agreement (APA) of DERM on malignant lesions is >80%

    Time frame: 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 outcomes

  1. Reproducibility: Average Negative Agreement (ANA) of DERM on benign lesions is >50%

    Time frame: 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.

  2. Repeatability: Average Negative Agreement (ANA) of DERM on benign lesions is >50%

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Skin Analytics Limited

Industry

Registry information

Official study title

A Precision Study To Demonstrate The Repeatability and Reproducability of DERM Outputs

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 23, 2024
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.