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NCT05126173 | Completed | Malignant Skin Melanoma T0


DERM US and EU Validation Study
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.

Condition or disease

Malignant Skin Melanoma T0

Basal Cell Carcinoma

Squamous Cell Carcinoma

Intervention/treatment

Deep Ensemble for the Recognition of Malignancy (DERM)

Study Type : Observational
Estimated Enrollment : 1111 participants
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
Actual Study Start Date : March 15, 2022
Estimated Primary Completion Date : August 19, 2022
Estimated Study Completion Date : September 15, 2022

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
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.

DERM US and EU Validation Study

Location Details


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DERM US and EU Validation Study

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

United States, California

Stanford university

Redwood City, California, United States, 94063

Not yet recruiting

United States, Florida

Vista Health Research, LLC

Miami, Florida, United States, 33176

Not yet recruiting

United States, Florida

Dorisca Research Consulting, LLC

Miami, Florida, United States, 34761

Not yet recruiting

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60208

Not yet recruiting

United States, Massachusetts

ALLCUTIS Research, LLC

Beverly, Massachusetts, United States, 01915

Not yet recruiting

United States, Massachusetts

Allcutis Research

Methuen, Massachusetts, United States, 01844

Not yet recruiting

United States, New York

Universal Dermatology, PLLC

Fairport, New York, United States, 14450

Not yet recruiting

United States, Pennsylvania

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213

Not yet recruiting

United States, Texas

Alpesh D. Desai, DO, PLLC, a Houston company institution

Houston, Texas, United States, 34761

Not yet recruiting

United States, Utah

University of Utah

Salt Lake City, Utah, United States, 84112

Not yet recruiting

Italy,

Universitaria Di Bologna

Bologna, Italy, 50100

Not yet recruiting

Italy,

Dermatology University of Florence

Firenze, Italy, 80131

Not yet recruiting

Italy,

Università degli Studi di Modena e Reggio Emilia

Modena, Italy, 28100

Not yet recruiting

Italy,

University of Campania

Napoli, Italy,

Not yet recruiting

Italy,

Università del Piemonte Orientale

Novara, Italy,

Not yet recruiting

Italy,

UOSD Dermatology Oncology

Roma, Italy,

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