DERM US and EU Validation Study

Completed

Conditions studied: Malignant Skin Melanoma T0, Basal Cell Carcinoma, Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT05126173

Run by

Skin Analytics Limited

People needed

1111

Starts

2022-03-15

Expected to finish

2022-09-15

Last updated by the study team

2023-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stanford university — Redwood City, California, United States
• Vista Health Research, LLC — Miami, Florida, United States
• Dorisca Research Consulting, LLC — Miami, Florida, United States
• Northwestern University — Chicago, Illinois, 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
• Universitaria Di Bologna — Bologna, Italy
• Dermatology University of Florence — Florence, Italy
• Università degli Studi di Modena e Reggio Emilia — Modena, Italy
• University of Campania — Naples, Italy
• Università del Piemonte Orientale — Novara, Italy
• UOSD Dermatology Oncology — Roma, Italy

Full record on ClinicalTrials.gov

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