Melanoma Clinical Trial

DERM US and EU Validation Study

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.

View Eligibility Criteria

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.

Study is for people with:

Melanoma

Estimated Enrollment:

1111

Study ID:

NCT05126173

Recruitment Status:

Completed

Sponsor:

Skin Analytics Limited

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There are 12 Locations for this study

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Stanford university
Redwood City California, 94063, United States
Vista Health Research, LLC
Miami Florida, 33176, United States
Dorisca Research Consulting, LLC
Miami Florida, 34761, United States
Northwestern University
Chicago Illinois, 60208, United States
ALLCUTIS Research, LLC
Beverly Massachusetts, 01915, United States
Allcutis Research
Methuen Massachusetts, 01844, United States
Universal Dermatology, PLLC
Fairport New York, 14450, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15213, United States
Alpesh D. Desai, DO, PLLC, a Houston company institution
Houston Texas, 34761, United States
University of Utah
Salt Lake City Utah, 84112, United States
Universitaria Di Bologna
Bologna , , Italy
Dermatology University of Florence
Firenze , 50100, Italy
Università degli Studi di Modena e Reggio Emilia
Modena , , Italy
University of Campania
Napoli , 80131, Italy
Università del Piemonte Orientale
Novara , 28100, Italy
UOSD Dermatology Oncology
Roma , , Italy

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Estimated Enrollment:

1111

Study ID:

NCT05126173

Recruitment Status:

Completed

Sponsor:


Skin Analytics Limited

How clear is this clinincal trial information?

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