TESTING nomela® ON SUSPICIOUS PIGMENTED NAEVI (C8)
Research type
Research Study
Full title
TESTING nomela® ON SUSPICIOUS PIGMENTED NAEVI (moles): a hospital-based study
IRAS ID
254451
Contact name
Peter Freedman
Contact email
Sponsor organisation
Moletest (Scotland) Ltd.
ISRCTN Number
ISRCTN99987356
Duration of Study in the UK
0 years, 6 months, 11 days
Research summary
Only some 3-5% of pigmented moles referred as suspicious from primary care are found to be melanoma by the specialist dermatologist. Up to 9 in 10 referred by the specialist for tissue examination (biopsy) are NOT melanoma. Can technology help to reduce referral and provide earlier reassurance to doctor and patient?
Nomela® is a professional screening test which takes high-quality photographs, using a dedicated iPad, analyses the digital image with special signal processing and produces an immediate result which provides support to help separate moles which are not melanoma. It is a test to help rule-out melanoma.
Previous work (Moletest004) established ranges for the image characteristics and separated approximately 50% as "no evidence of melanoma" meaning that specialist referral of this group would not have been required.
Current work (C7) is allowing refinement of these ranges and is expected to increase the proportion of this group.
More information is being sought to enhance the confidence that the ranges chosen separate a useful group safely that is with no, or very low, incorrect test results.
This Study (C8) tests nomela® on skin lesions referred by the specialist for biopsy/excision, collects the biopsy results and then demonstrates the performance of nomela®. The clinical decision to send for tissue examination and all aspects of clinical management remain unaffected for those participating in the Study.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
19/EE/0041
Date of REC Opinion
11 Apr 2019
REC opinion
Further Information Favourable Opinion