DERM US and EU Validation Study

Skin Analytics

Status: Completed

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

Treatments: Device: Deep Ensemble for the Recognition of Malignancy (DERM)

Study type: Observational

Funder types: Industry

Identifiers

NCT05126173

DERM-006

Details and patient eligibility

About

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.

Enrollment: 1,111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.