Clinical trial NCT05126173: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Skin Melanoma T0
Basal Cell Carcinoma
Squamous Cell Carcinoma
Lead sponsor: Skin Analytics Limited
Sponsor class: INDUSTRY
First posted: 2021-11-18
Enrollment: 1111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Sensitivity of DERM to detect "Malignant conditions"
timeFrame: Through study completion, on average of 1 day
measure: Specificity of DERM to detect Malignant conditions.
timeFrame: Through study completion, on average of 1 day
Secondary outcomes:
measure: Sensitivity of DERM to detect Melanoma
timeFrame: Through study completion, on average of 1 day
measure: Specificity of DERM to detect Melanoma
timeFrame: Through study completion, on average of 1 day
measure: Sensitivity of DERM to detect Squamous Cell Carcinoma
timeFrame: Through study completion, on average of 1 day
measure: Specificity of DERM to detect Squamous Cell Carcinoma
timeFrame: Through study completion, on average of 1 day
measure: Sensitivity of DERM to detect Basal Cell Carcinoma
timeFrame: Through study completion, on average of 1 day
measure: Specificity of DERM to detect Basal Cell Carcinoma
timeFrame: Through study completion, on average of 1 day
measure: Accuracy of mole/not mole algorithm
timeFrame: Through study completion, on average of 1 day
Other outcomes:
measure: Diagnostic accuracy measures
timeFrame: Through study completion, on average of 1 day
measure: Probability that the most probable lesion label DERM returns matches the lesion diagnosis
timeFrame: Through study completion, on average of 1 day
measure: The impact of patient characteristics on the diagnostic accuracy of DERM
timeFrame: Through study completion, on average of 1 day
measure: The impact of lesions characteristic on the diagnostic accuracy of DERM
timeFrame: Through study completion, on average of 1 day
measure: AUROC of DERM to identify malignant conditions for each individual camera / lens type
timeFrame: Through study completion, on average of 1 day
measure: Concordance of DERM results by each individual camera / lens type
timeFrame: Through study completion, on average of 1 day
measure: Strength of association between correct classification and acceptance/rejection status of images
timeFrame: Through study completion, on average of 1 day
measure: AUROC of DERM when macro images are used both to train the algorithm and as test images
timeFrame: Through study completion, on average of 1 day
measure: Correlation between clinician assessment of likelihood of skin cancer with histopathology diagnosis
timeFrame: Through study completion, on average of 1 day
measure: Percentage of images taken that are rejected by the IQ check (MoleNotMole + Image Quality), where a second image is successfully taken
timeFrame: Through study completion, on average of 1 day
Locations:
city: Redwood City
country: United States
facility: Stanford university
state: California
city: Miami
country: United States
facility: Vista Health Research, LLC
state: Florida
city: Miami
country: United States
facility: Dorisca Research Consulting, LLC
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Beverly
country: United States
facility: ALLCUTIS Research, LLC
state: Massachusetts
city: Methuen
country: United States
facility: Allcutis Research
state: Massachusetts
city: Fairport
country: United States
facility: Universal Dermatology, PLLC
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: Alpesh D. Desai, DO, PLLC, a Houston company institution
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Bologna
country: Italy
facility: Universitaria Di Bologna
city: Firenze
country: Italy
facility: Dermatology University of Florence
city: Modena
country: Italy
facility: Università degli Studi di Modena e Reggio Emilia
city: Napoli
country: Italy
facility: University of Campania
city: Novara
country: Italy
facility: Università del Piemonte Orientale
city: Roma
country: Italy
facility: UOSD Dermatology Oncology
Study officials:
References: