DERM US and EU Validation Study

Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05126173
• Other study ID #: DERM-006
• Status: Completed
• Start date: March 15, 2022
• Est. completion date: September 15, 2022

Study information

• Verified date: June 2023
• Source: Skin Analytics Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1111
• Est. completion date: September 15, 2022
• Est. primary completion date: August 19, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Italy	Universitaria Di Bologna	Bologna
Italy	Dermatology University of Florence	Firenze
Italy	Università degli Studi di Modena e Reggio Emilia	Modena
Italy	University of Campania	Napoli
Italy	Università del Piemonte Orientale	Novara
Italy	UOSD Dermatology Oncology	Roma
United States	ALLCUTIS Research, LLC	Beverly	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	Universal Dermatology, PLLC	Fairport	New York
United States	Alpesh D. Desai, DO, PLLC, a Houston company institution	Houston	Texas
United States	Allcutis Research	Methuen	Massachusetts
United States	Dorisca Research Consulting, LLC	Miami	Florida
United States	Vista Health Research, LLC	Miami	Florida
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Stanford university	Redwood City	California
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Skin Analytics Limited

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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	Sensitivity of DERM to detect Melanoma	Sensitivity of DERM to detect Melanoma	Through study completion, on average of 1 day
Secondary	Specificity of DERM to detect Melanoma	Specificity of DERM to detect Melanoma	Through study completion, on average of 1 day
Secondary	Sensitivity of DERM to detect Squamous Cell Carcinoma	Sensitivity of DERM to correctly classify SCC	Through study completion, on average of 1 day
Secondary	Specificity of DERM to detect Squamous Cell Carcinoma	Specificity of DERM to correctly classify SCC	Through study completion, on average of 1 day
Secondary	Sensitivity of DERM to detect Basal Cell Carcinoma	Sensitivity of DERM to correctly classify BCC	Through study completion, on average of 1 day
Secondary	Specificity of DERM to detect Basal Cell Carcinoma	Specificity of DERM to correctly classify BCC	Through study completion, on average of 1 day
Secondary	Accuracy of mole/not mole algorithm	Accuracy of mole/not mole algorithm	Through study completion, on average of 1 day