DERM US and EU Validation Study

A Clinical Validation Study to Demonstrate the Effectiveness of an Artificial Intelligence Algorithm (DERM) to Identify Skin Cancer in Patients Undergoing a Skin Biopsy

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.

Study Overview

• Status: Completed
• Conditions: Basal Cell Carcinoma; Squamous Cell Carcinoma; Malignant Skin Melanoma T0
• Intervention / Treatment: Device: Deep Ensemble for the Recognition of Malignancy (DERM)

• Study Type: Observational
• Enrollment (Actual): 1111

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy
    • Universitaria Di Bologna
  • Firenze, Italy, 50100
    • Dermatology University of Florence
  • Modena, Italy
    • Università degli Studi di Modena e Reggio Emilia
  • Napoli, Italy, 80131
    • University of Campania
  • Novara, Italy, 28100
    • Università del Piemonte orientale
  • Roma, Italy
    • UOSD Dermatology Oncology
• United States
  • California
    • Redwood City, California, United States, 94063
      • Stanford University
  • Florida
    • Miami, Florida, United States, 33176
      • Vista Health Research, LLC
    • Miami, Florida, United States, 34761
      • Dorisca Research Consulting, LLC
  • Illinois
    • Chicago, Illinois, United States, 60208
      • Northwestern University
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • ALLCUTIS Research, LLC
    • Methuen, Massachusetts, United States, 01844
      • Allcutis Research
  • New York
    • Fairport, New York, United States, 14450
      • Universal Dermatology, PLLC
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Texas
    • Houston, Texas, United States, 34761
      • Alpesh D. Desai, DO, PLLC, a Houston company institution
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of DERM to detect "Malignant conditions"	Sensitivity of DERM to detect Melanoma, SCC and BCC combined	Through study completion, on average of 1 day
Specificity of DERM to detect Malignant conditions.	Specificity of DERM to detect Melanoma, SCC and BCC combined	Through study completion, on average of 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of DERM to detect Melanoma	Sensitivity of DERM to detect Melanoma	Through study completion, on average of 1 day
Specificity of DERM to detect Melanoma	Specificity of DERM to detect Melanoma	Through study completion, on average of 1 day
Sensitivity of DERM to detect Squamous Cell Carcinoma	Sensitivity of DERM to correctly classify SCC	Through study completion, on average of 1 day
Specificity of DERM to detect Squamous Cell Carcinoma	Specificity of DERM to correctly classify SCC	Through study completion, on average of 1 day
Sensitivity of DERM to detect Basal Cell Carcinoma	Sensitivity of DERM to correctly classify BCC	Through study completion, on average of 1 day
Specificity of DERM to detect Basal Cell Carcinoma	Specificity of DERM to correctly classify BCC	Through study completion, on average of 1 day
Accuracy of mole/not mole algorithm	Accuracy of mole/not mole algorithm	Through study completion, on average of 1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy measures	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	Through study completion, on average of 1 day
Probability that the most probable lesion label DERM returns matches the lesion diagnosis	Probability that the alternative classification label DERM that returns, matches the lesion diagnosis	Through study completion, on average of 1 day
The impact of patient characteristics on the diagnostic accuracy of DERM	Such as sex, age, and Fitzpatrick skin type	Through study completion, on average of 1 day
The impact of lesions characteristic on the diagnostic accuracy of DERM	Such as location, size, growth, stage and sub-type	Through study completion, on average of 1 day
AUROC of DERM to identify malignant conditions for each individual camera / lens type	AUROC of DERM to identify malignant conditions for each individual camera / lens type	Through study completion, on average of 1 day
Concordance of DERM results by each individual camera / lens type	Concordance of DERM results by each individual camera / lens type	Through study completion, on average of 1 day
Strength of association between correct classification and acceptance/rejection status of images	Strength of association between correct classification and acceptance/rejection status of images	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	AUROC of DERM when macro images are used both to train the algorithm and as test images	Through study completion, on average of 1 day
Correlation between clinician assessment of likelihood of skin cancer with histopathology diagnosis	Correlation between clinician assessment of likelihood of skin cancer with histopathology diagnosis	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	Percentage of images taken that are rejected by the IQ check (MoleNotMole + Image Quality), where a second image is successfully taken	Through study completion, on average of 1 day

Collaborators and Investigators

• Sponsor: Skin Analytics Limited

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): August 19, 2022
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma; Carcinoma, Basal Cell
• Other Study ID Numbers: DERM-006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No