DERM US and EU Validation Study

• ClinicalTrials.gov Identifier: NCT05126173
• Recruitment Status: Completed
• First Posted: November 18, 2021
• Last Update Posted: June 28, 2023
• Sponsor: Skin Analytics Limited
• Information provided by (Responsible Party): Skin Analytics Limited

Tracking Information

• First Submitted Date: October 18, 2021
• First Posted Date: November 18, 2021
• Last Update Posted Date: June 28, 2023
• Actual Study Start Date: March 15, 2022
• Actual Primary Completion Date: August 19, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 16, 2021)

• 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
• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 16, 2021)

• Sensitivity of DERM to detect Melanoma [ Time Frame: Through study completion, on average of 1 day ]
  Sensitivity of DERM to detect Melanoma
• Specificity of DERM to detect Melanoma [ Time Frame: Through study completion, on average of 1 day ]
  Specificity of DERM to detect Melanoma
• 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
• 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
• 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
• 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
• Accuracy of mole/not mole algorithm [ Time Frame: Through study completion, on average of 1 day ]
  Accuracy of mole/not mole algorithm

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: November 16, 2021)

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: DERM US and EU Validation Study
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Malignant Skin Melanoma T0
• Basal Cell Carcinoma
• Squamous Cell Carcinoma

Intervention

Device: Deep Ensemble for the Recognition of Malignancy (DERM)

An AI-based diagnosis support tool

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 26, 2023): 1111
• Original Estimated Enrollment (submitted: November 16, 2021): 1200
• Actual Study Completion Date: September 15, 2022
• Actual Primary Completion Date: August 19, 2022 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy, United States

Administrative Information

• NCT Number: NCT05126173
• Other Study ID Numbers: DERM-006
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Skin Analytics Limited
• Original Responsible Party: Same as current
• Current Study Sponsor: Skin Analytics Limited
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Skin Analytics Limited
• Verification Date: June 2023