Title:	Molemate: The management of suspicious lesions in primary care
Project Description:	To assess whether using the MoleMate system (SIAscopy plus an algorithm specifically developed for primary care) will lead to more accurate diagnosis of suspicious pigmented lesions in primary care.
Background:	Suspicious pigmented lesions or ‘moles’ are a common presenting problem in general practice consultations, and while the majority are benign, a small minority are malignant melanomas. Over the last twenty-five years, the incidence of melanoma has increased more than for any other major cancer in the UK, to 8,000 new cases and 1,800 deaths annually. Worldwide, the incidence of melanoma is increasing faster than any other cancer with an approximate doubling of rates every 10-20 years in countries with white populations. While the incidence in the UK is one of the highest in Europe, it is lower than the reported incidence from other countries such as Australia and New Zealand. Furthermore, although the incidence of melanoma increases with age, a third of all cases occur in people aged less than fifty years and it is the second most common cancer in the 20-39 age-group. The increasing incidence has been attributed to increases in UV exposure, both natural and artificial, and to associated advances in early diagnosis. Other risk factors include genetic predisposition, fair complexion, sunburn-susceptible skin types, and family history (only 1% of UK patients).
Methodology description:	A randomised controlled trial (RCT) will be used to assess the MoleMate system in fifteen practices. Trial participants will be randomised to either the control group, where their mole will be examined by eye (current ‘best practice’) or the intervention group, where their mole will be examined using the MoleMate system. The trial will compare the use of the MoleMate system with current ‘best practice’ on the accurate diagnosis and appropriate referral of suspicious pigmented lesions to secondary care. For this purpose, the definition of ‘suspicious pigmented lesion’ is any lesion presented by a patient, or opportunistically seen by a doctor, which cannot immediately be diagnosed as benign and the patient reassured.
Sample group description:	All patients of 18 years or over, attending a GP or practice nurse appointment at a study practice will be eligible to join the trial. The entry criteria are that the patient or practitioner describes a pigmented lesion, although the lesion need not be the presenting symptom. Patients excluded from the trial include those who are immediately reassured that their mole is benign; patients who do not give their consent or are not able to understand the consent process; and patients felt unsuitable by their GP due to other on-going physical or psychological conditions such as cognitive impairment or serious illness. The study aims to recruit 1800 participants from 15 practices (intervention group 900; control group 900) over a trial period of 16 to 28 months per practice.
Outcome measure description:	The primary outcome will be the appropriateness of referrals to secondary care. This will be measured by the number of pigmented lesions removed and biopsied as a proportion of the number of pigmented lesions referred to secondary care. The results for the control group can then be compared to the intervention group to determine if the use of the MoleMate system does improve the accuracy of diagnosis. Secondary outcomes will include clinician performance, learning effects, frequency of use, and confidence in use of the MoleMate system; patient satisfaction and anxiety; biopsy results, and cost-effectiveness.
UK ISRCT Number:	79932379
Project organisation
Start date:	1st April 2007
End date:	31st December 2010
Contact person:	Dr Fiona Walter
Contact Details:	Strangeways Research Laboratory Worts Causeway Cambridge Cambs CB1 8RN UK Telephone: (01223) 330323 Fax: E-mail: fmw22@medschl.cam.ac.uk
Funding information
Funding Organisation:	NIHR School for Primary Care Research
Funding Reference:
Funding Amount:	£309,035
Further Information, References and Publications
The MoleMate systems for the trial were kindly supplied by Astron Clinica. In August 2009, Astron Clinica Ltd was taken over by Biocompatibles International plc, by BTG (British Technology Group) in January 2011 and in June 2011 by MedX Health.