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Clinical Trial Summary

Prospective, single-arm, cross-sectional, study to establish the effectiveness of MIAA to detect melanoma in pigmented lesions, compared to gold standard histological determination.


Clinical Trial Description

Skin Analytics Limited have developed an algorithm (MIAA) which reviews photographs of pigmented lesions to determine whether melanoma is likely to be present. This study aims to establish how well MIAA determines the presence or absence of melanoma, compared to a biopsy.

Pigmented lesions that a dermatologist has decided to biopsy, and are suitable for photographing, will be photographed up to five times in a single visit. Three different camera will be used, and two different dermoscopic lens attachments will be used on smartphone cameras. Images will be analysed by MIAA and the results compared to the biopsy result. Clinicians, patients and the statistical analysis team will be blinded to the result of MIAA.

At least 65 pigmented lesions positive for melanoma (as determined by biopsy) are required, which is predicted to mean 1250 patients will be recruited. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02612168
Study type Interventional
Source Skin Analytics Limited
Contact
Status Completed
Phase N/A
Start date January 11, 2017
Completion date July 11, 2018

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