DERM US and EU Validation Study

Completed

• Conditions: Malignant Skin Melanoma T0; Basal Cell Carcinoma; Squamous Cell Carcinoma

• Registration Number: NCT05126173
• Lead Sponsor: Skin Analytics Limited

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 available

Study Timeline

• Study First Submitted: 2021-10-18
• Study First Submitted QC: 2021-11-16
• Study First Posted: 2021-11-18
• Study Start: 2022-03-15
• Primary Completion: 2022-08-19
• Study Completion: 2022-09-15
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-26
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1111

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (16)

UOSD Dermatology Oncology; 🇮🇹 Roma, Italy

Universitaria Di Bologna; 🇮🇹 Bologna, Italy

Dorisca Research Consulting, LLC; 🇺🇸 Miami, Florida, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Vista Health Research, LLC; 🇺🇸 Miami, Florida, United States

ALLCUTIS Research, LLC; 🇺🇸 Beverly, Massachusetts, United States

Allcutis Research; 🇺🇸 Methuen, Massachusetts, United States

Universal Dermatology, PLLC; 🇺🇸 Fairport, New York, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Alpesh D. Desai, DO, PLLC, a Houston company institution; 🇺🇸 Houston, Texas, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

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

Stanford university; 🇺🇸 Redwood City, California, United States