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Completed

NCT Number: NCT04116983

DERM NMSC Validation Study

This study aims to establish the effectiveness of an Artificial Intelligence (AI) algorithm (DERM) to determine the presence of Basal Cell Carcinoma (BCC) and Squamous Cell Carcinoma (SCC) and frequently observed benign conditions, when used to analyse images of skin lesions taken by commonly available smart phone cameras.

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Key information

Conditions

Non-Melanoma Skin Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Free London NHS Foundation Trust, London, United Kingdom

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About this study

DERM, an Artificial Intelligence (AI)-based diagnosis support tool, has been shown to be able to accurately identify Non-melanoma skin cancers (NMSC) and other conditions from historical images of suspicious skin lesions (moles). This study aims to establish how well DERM determines the presence of these conditions in images of skin lesions collected in a clinical setting.

Suspicious skin lesions that are due to be assessed by a dermatologist and a patch of healthy skin will be photographed using three commonly available smart phone cameras with a specific lens attachment. The images will be analysed by DERM, and the results compared to the clinician's diagnosis (all lesions) and histologically-conformed diagnosis (any lesion that is biopsied).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participant is willing and able to give informed consent for participation in the study,
  • Male or Female, aged 18 years or above,
  • Have at least suspicious skin lesion which is suitable for photographing (<15mm, not located on an anatomical site inappropriate to photograph (genitalia, hair-bearing areas, under nails), not previously biopsied, not located in an area of visible scarring or tattooing),
  • In the Investigator's opinion, able and willing to comply with all study requirements.

Exclusion criteria

  • 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

Treatment and study plan

Deep Ensemble for the Recognition of Malignancy (DERM)

Device

An AI-based diagnosis support tool

Primary outcomes

  1. AUROC of DERM performance when analysing images of biopsied lesions

    Time frame: Study completion

    Area Under the Receiver Operating Characteristic Curve (AUROC) of the DERM result of biopsied lesions, using histopathological-confirmed diagnosis as gold standard

Secondary outcomes

  1. AUROC of DERM performance when analysing images of non-biopsied lesions

    Time frame: Study completion: on average 2 days

    Area Under the Receiver Operating Characteristic Curve (AUROC) of the DERM result of biopsied lesions, using clinical diagnosis as gold standard

  2. The sensitivity of DERM when used to assess biopsied lesions

    Time frame: Study completion: on average 2 days

    The sensitivity of DERM when used to assess biopsied lesions

  3. The specificity of DERM when used to assess biopsied lesions

    Time frame: Study completion: on average 2 days

    The specificity of DERM when used to assess biopsied lesions

  4. The false positive rate of DERM when used to assess biopsied lesions

    Time frame: Study completion: on average 2 days

    The false positive rate of DERM when used to assess biopsied lesions

  5. The false negative rate of DERM when used to assess biopsied lesions

    Time frame: Study completion: on average 2 days

    The false negative rate of DERM when used to assess biopsied lesions

  6. The positive predictive value of DERM when used to assess biopsied lesions

    Time frame: Study completion: on average 2 days

    The positive predictive value of DERM when used to assess biopsied lesions

  7. The negative predictive value of DERM when used to assess biopsied lesions

    Time frame: Study completion: on average 2 days

    The negative predictive value of DERM when used to assess biopsied lesions

  8. The sensitivity of DERM when used to assess non-biopsied lesions

    Time frame: Study completion: on average 2 days

    The sensitivity of DERM when used to assess non-biopsied lesions

  9. The specificity of DERM when used to assess non-biopsied lesions

    Time frame: Study completion: on average 2 days

    The specificity of DERM when used to assess non-biopsied lesions

  10. The false positive rate of DERM when used to assess non-biopsied lesions

    Time frame: Study completion: on average 2 days

    The false positive rate of DERM when used to assess non-biopsied lesions

  11. The false negative rate of DERM when used to assess non-biopsied lesions

    Time frame: Study completion: on average 2 days

    The false negative rate of DERM when used to assess non-biopsied lesions

  12. The positive predictive value of DERM when used to assess non-biopsied lesions

    Time frame: Study completion: on average 2 days

    The positive predictive value of DERM when used to assess non-biopsied lesions

  13. The negative predictive value of DERM when used to assess non-biopsied lesions

    Time frame: Study completion: on average 2 days

    The negative predictive value of DERM when used to assess non-biopsied lesions

  14. Concordance of clinician assessment with histologically confirmed diagnosis

    Time frame: Study completion: on average 2 days

    Concordance of clinician assessment with histologically confirmed diagnosis

  15. The concordance of DERM result generated using images from each camera

    Time frame: Study completion: on average 2 days

    The concordance of DERM result generated using images from each camera

  16. The proportion of skin lesions with 3 images that can be analysed by DERM;

    Time frame: Study completion: on average 2 days

    The proportion of skin lesions with 3 images that can be analysed by DERM;

  17. The proportion of skin lesions with at least 1 readable image that can be analysed by DERM

    Time frame: Study completion: on average 2 days

    The proportion of skin lesions with at least 1 readable image that can be analysed by DERM

Other outcomes

  1. Impact of patient characteristics on the DERM and clinician assessment

    Time frame: Study completion: on average 2 days

    The impact of patient characteristics (such as sex, age, location of lesion, total body lesion count, Fitzpatrick skin type, past medical history of skin cancer) on the diagnostic accuracy of DERM and clinician assessment;

  2. Impact of lesion characteristics on the DERM and clinician assessment

    Time frame: Study completion: on average 2 days

    The impact of lesions characteristic (such as growth over last 6 months, stage and sub-type) on the diagnostic accuracy of DERM and clinician assessment

  3. The impact of image variables on the diagnostic accuracy of DERM assessment

    Time frame: Study completion: on average 2 days

    The impact of image variables (such as macro and dermoscopic images) on the diagnostic accuracy of DERM assessment

  4. DERM performance (AUROC) when macro images are used both to train the algorithm and as test images

    Time frame: Study completion: on average 2 days

    Exploration of whether macro images can be used as part of DERM's assessment

Sponsors and collaborators

Lead sponsor

Skin Analytics Limited

Industry

Collaborators

  • Innovate UK

Registry information

Official study title

Effectiveness of an Image Analysing Algorithm (DERM) to Diagnose Non-melanoma Skin Cancer (NMSC) and Benign Skin Lesions Compared to Gold Standard Clinical and Histological Diagnosis

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 7, 2019
Registry last updated
May 18, 2022

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.

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