Reflectance Confocal Microscopy to diagnose malignant melanoma and LM.
Research type
Research Study
Full title
Reflectance Confocal Microscopy (RCM) to diagnose malignant melanoma and LM
IRAS ID
218996
Contact name
Howard Stevens
Contact email
Sponsor organisation
Skin Care Network Barnet Ltd
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
Investigation of the diagnostic power of confocal microscopy in the identification of malignant melanoma and lentigo melanoma.
Patients commonly present to a dermatologist with one or more suspicious looking pigmented lesions. There are clearly documented protocols for visual observation, both with the naked eye and with an illuminated magnifying glass called a dermatoscope. Because many diagnostic features of melanoma are sub-cellular, and because melanoma can be very dangerous, clinicians must be very cautious and will take a biopsy, a sample of the lesion, where there is any doubt. It is not unusual for 10, 15 or more biopsies to be taken for each cancer found. This figure is known as the ‘Number Needed to Excise (NNE)’.
Confocal microscopy allows the sub-cellular structure of the skin to be visualised without needing to first take a biopsy. International studies have shown that this can reduce the NNE significantly without resulting in any more cancers being missed. The instrument used has been available commercially for 10 years, holds a medical CE mark, and is being used within the intended purpose of that mark. This study aims to verify whether the use of confocal microscopy would enable similar improvements in NNE in a UK population.
The study is purely observational. Patients attending Skin Care Network who have lesions that are sufficiently suspicious to require a biopsy under normal standards of care will be invited to participate. Once the images have been taken, the patient will be returned to normal standard of care. The confocal images will not be used to influence the treatment given.
REC name
Wales REC 7
REC reference
17/WA/0044
Date of REC Opinion
10 Mar 2017
REC opinion
Further Information Favourable Opinion