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DERM US and EU Validation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05126173
Recruitment Status : Completed
First Posted : November 18, 2021
Last Update Posted : June 28, 2023
Sponsor:
Information provided by (Responsible Party):
Skin Analytics Limited

Study Description
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Brief Summary:
This study aims establish the effectiveness of Image Analysing Algorithm (DERM) to identify melanoma, Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC) when used to analyse dermoscopic images of skin lesions within the US and European population.

Condition or disease Intervention/treatment
Malignant Skin Melanoma T0 Basal Cell Carcinoma Squamous Cell Carcinoma Device: Deep Ensemble for the Recognition of Malignancy (DERM)

Study Design
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Study Type : Observational
Actual Enrollment : 1111 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Clinical Validation Study to Demonstrate the Effectiveness of an Artificial Intelligence Algorithm (DERM) to Identify Skin Cancer in Patients Undergoing a Skin Biopsy
Actual Study Start Date : March 15, 2022
Actual Primary Completion Date : August 19, 2022
Actual Study Completion Date : September 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Groups and Cohorts
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Intervention Details:
  • Device: Deep Ensemble for the Recognition of Malignancy (DERM)
    An AI-based diagnosis support tool

Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity of DERM to detect "Malignant conditions" [ Time Frame: Through study completion, on average of 1 day ]
    Sensitivity of DERM to detect Melanoma, SCC and BCC combined

  2. Specificity of DERM to detect Malignant conditions. [ Time Frame: Through study completion, on average of 1 day ]
    Specificity of DERM to detect Melanoma, SCC and BCC combined


Secondary Outcome Measures :
  1. Sensitivity of DERM to detect Melanoma [ Time Frame: Through study completion, on average of 1 day ]
    Sensitivity of DERM to detect Melanoma

  2. Specificity of DERM to detect Melanoma [ Time Frame: Through study completion, on average of 1 day ]
    Specificity of DERM to detect Melanoma

  3. Sensitivity of DERM to detect Squamous Cell Carcinoma [ Time Frame: Through study completion, on average of 1 day ]
    Sensitivity of DERM to correctly classify SCC

  4. Specificity of DERM to detect Squamous Cell Carcinoma [ Time Frame: Through study completion, on average of 1 day ]
    Specificity of DERM to correctly classify SCC

  5. Sensitivity of DERM to detect Basal Cell Carcinoma [ Time Frame: Through study completion, on average of 1 day ]
    Sensitivity of DERM to correctly classify BCC

  6. Specificity of DERM to detect Basal Cell Carcinoma [ Time Frame: Through study completion, on average of 1 day ]
    Specificity of DERM to correctly classify BCC

  7. Accuracy of mole/not mole algorithm [ Time Frame: Through study completion, on average of 1 day ]
    Accuracy of mole/not mole algorithm


Other Outcome Measures:
  1. Diagnostic accuracy measures [ Time Frame: Through study completion, on average of 1 day ]
    AUROC, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) etc. of DERM to detect melanoma, SCC, BCC, premalignant, and benign conditions grouped and individually

  2. Probability that the most probable lesion label DERM returns matches the lesion diagnosis [ Time Frame: Through study completion, on average of 1 day ]
    Probability that the alternative classification label DERM that returns, matches the lesion diagnosis

  3. The impact of patient characteristics on the diagnostic accuracy of DERM [ Time Frame: Through study completion, on average of 1 day ]
    Such as sex, age, and Fitzpatrick skin type

  4. The impact of lesions characteristic on the diagnostic accuracy of DERM [ Time Frame: Through study completion, on average of 1 day ]
    Such as location, size, growth, stage and sub-type

  5. AUROC of DERM to identify malignant conditions for each individual camera / lens type [ Time Frame: Through study completion, on average of 1 day ]
    AUROC of DERM to identify malignant conditions for each individual camera / lens type

  6. Concordance of DERM results by each individual camera / lens type [ Time Frame: Through study completion, on average of 1 day ]
    Concordance of DERM results by each individual camera / lens type

  7. Strength of association between correct classification and acceptance/rejection status of images [ Time Frame: Through study completion, on average of 1 day ]
    Strength of association between correct classification and acceptance/rejection status of images

  8. AUROC of DERM when macro images are used both to train the algorithm and as test images [ Time Frame: Through study completion, on average of 1 day ]
    AUROC of DERM when macro images are used both to train the algorithm and as test images

  9. Correlation between clinician assessment of likelihood of skin cancer with histopathology diagnosis [ Time Frame: Through study completion, on average of 1 day ]
    Correlation between clinician assessment of likelihood of skin cancer with histopathology diagnosis

  10. Percentage of images taken that are rejected by the IQ check (MoleNotMole + Image Quality), where a second image is successfully taken [ Time Frame: Through study completion, on average of 1 day ]
    Percentage of images taken that are rejected by the IQ check (MoleNotMole + Image Quality), where a second image is successfully taken


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients attending a dermatology clinic with at least one skin lesion that will be biopsied due to a suspicion of skin cancer will be eligible for the study.
Criteria

Inclusion Criteria:

  • Willing and able to give informed consent for participation in the study,
  • Male or Female, aged 18 years or above,
  • Have at least one suitable skin lesion that will be biopsied due to a suspicion of skin cancer,

To be suitable for inclusion, a skin lesion must NOT have ANY of the following limitations:

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), a diameter greater than the diameter of the dermoscopic lenses, located on an anatomical site unsuitable for photographing, including on surface of genitals and hair-bearing areas, has been previously biopsied, excised, treated or otherwise traumatised, 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05126173


Locations
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United States, California
Stanford university
Redwood City, California, United States, 94063
United States, Florida
Vista Health Research, LLC
Miami, Florida, United States, 33176
Dorisca Research Consulting, LLC
Miami, Florida, United States, 34761
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60208
United States, Massachusetts
ALLCUTIS Research, LLC
Beverly, Massachusetts, United States, 01915
Allcutis Research
Methuen, Massachusetts, United States, 01844
United States, New York
Universal Dermatology, PLLC
Fairport, New York, United States, 14450
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Alpesh D. Desai, DO, PLLC, a Houston company institution
Houston, Texas, United States, 34761
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Italy
Universitaria Di Bologna
Bologna, Italy
Dermatology University of Florence
Firenze, Italy, 50100
Università degli Studi di Modena e Reggio Emilia
Modena, Italy
University of Campania
Napoli, Italy, 80131
Università del Piemonte Orientale
Novara, Italy, 28100
UOSD Dermatology Oncology
Roma, Italy
Sponsors and Collaborators
Skin Analytics Limited
More Information
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Responsible Party: Skin Analytics Limited
ClinicalTrials.gov Identifier: NCT05126173    
Other Study ID Numbers: DERM-006
First Posted: November 18, 2021    Key Record Dates
Last Update Posted: June 28, 2023
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell