MIAA Validation Study - protocol version 1

• Research type

  Research Study

• Full title

  Effectiveness of an image analysing algorithm (MIAA) to diagnose melanoma compared to gold standard histological determination.

• IRAS ID

  194984

• Contact name

  Neil Daly

• Contact email

  neil@skinanalytics.co.uk

• Sponsor organisation

  Skin Analytics

• Clinicaltrials.gov Identifier

  NCT02612168

• Duration of Study in the UK

  0 years, 8 months, 28 days

• Research summary

  The sponsor has 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. All moles that a dermatologist has decided to biopsy, and are suitable for photographing, plus two moles that will not be biopsied, will be photographed. These will be taken on commonly available cameras with lens attachments and the sponsor's own dermascopic imaging device (DIT). The images taken will be subject to analysis by MIAA. The results from MIAA and the biopsy (or clinician's assessment for the non-biopsied moles) will be compared.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  16/EM/0194

• Date of REC Opinion

  6 Jun 2016

• REC opinion

  Further Information Favourable Opinion