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The MoleMate™ UK Trial: The management of suspicious pigmented lesions in primary care
ISRCTN ISRCTN79932379
DOI 10.1186/ISRCTN79932379
ClinicalTrials.gov identifier
EudraCT number
Public title The MoleMate™ UK Trial: The management of suspicious pigmented lesions in primary care
Scientific title
Acronym N/A
Serial number at source N/A
Study hypothesis Suspicious pigmented lesions 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. Studies suggest that general practitioners (GPs) are poor at differentiating melanomas from other pigmented lesions, and training GPs in melanoma diagnosis appears to have little significant effect on their performance. Alternative approaches are therefore required to increase the precision of assessment of pigmented skin lesions in primary care.

The MoleMate™ UK Trial, set in UK general practice, aims to test the hypothesis that the use of the MoleMate system will improve the effectiveness of management of suspicious pigmented lesions in primary care.

Please note that as of 04/01/10 the sources of funding for this trial have been updated. Biocompatibles UK Ltd will supply the MoleMate systems for the trial, in place of Astron Clinica.
Lay summary Not provided at time of registration
Ethics approval Approval received from the Cambridgeshire 2 Research Ethics Committee on the 26th October 2007. REC Reference Number: 07/H0308/167
Study design Multi-centre randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Pigmented lesions/ diagnosis of melanoma
Participants - inclusion criteria 1. 18 years or over
2. Attending a GP or practice nurse appointment at a study general practice
3. The patient or practitioner describes a pigmented lesion, although the lesion need not be the presenting symptom
Participants - exclusion criteria 1. Patients with a pigmented lesion which is immediately diagnosed as benign and the patient reassured
2. Patients who do not give their consent or are not able to understand the consent process
3. Patients felt unsuitable by their GP due to other on-going physical or psychological conditions such as cognitive impairment, serious illness
Anticipated start date 01/01/2008
Anticipated end date 30/06/2010
Status of trial Completed
Patient information material Participant information sheet: http://www.medschl.cam.ac.uk/gppcru/Projects/MoleMate/downloads.htm
Target number of participants 1,800 participants from 15 general practices
Interventions The study aims to recruit 1,800 participants from 15 general practices (intervention group 900; control group 900) over a trial period of 16 months per practice.

Patients who are eligible and agree to participate will be randomised to either the control group, where the lesion will be assessed by eye according to current 'best practice', or the intervention group, where the lesion will be assessed by eye according to current 'best practice' followed by an assessment of the lesion using the MoleMate system. A clinical decision will then be made and the participant either reassured or referred to dermatology.

All participants will be asked to complete an exit questionnaire within one week of their appointment and a follow-up questionnaire after 3 months.
Primary outcome measure(s) The proportion of referred pigmented lesions that are monitored or biopsied from the intervention group compared with the proportion of referred pigmented lesions that are monitored or biopsied from the control group. This will reflect the extent to which use of the MoleMate system in primary care increases the diagnostic accuracy and appropriateness of referrals to secondary care.
Secondary outcome measure(s) 1. Assessment of participant satisfaction and anxiety at one week and three months after the consultation in general practice
2. Comparison of the diagnostic performance of clinicians with the MoleMate system and without
3. Assessment of clinician learning when using the MoleMate system
4. Assessment of clinician confidence in the MoleMate system
5. Examination of the association between the 'Index of Suspicion' scale and the seven-point checklist, and their predictiveness of lesion outcomes
6. Economic analysis of using the MoleMate system in primary care
7. Creation of a cohort of participants from the trial who will have melanoma-specific diagnosis and mortality over 5-years survival outcomes assessed
Sources of funding 1. The NHS National Institute for Health Research (NIHR): School for Primary Care Research (main funder) (UK)
2. Biocompatibles UK Limited have supplied the MoleMate systems for the trial.
3. Cambridge R & D Consortium - Cambridgeshire Primary Care Trust transitional funding is providing service support for the additional consultations in general practices (UK)
Trial website http://www.medschl.cam.ac.uk/gppcru/Projects/MoleMate/
Publications 1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20459846
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20807441
3. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22763392
Contact name Dr  Fiona  Walter
  Address General Practice and Primary Care Research Unit
Institute of Public Health
University Forvie Site
  City/town Cambridge
  Zip/Postcode CB2 0SR
  Country United Kingdom
Sponsor University of Cambridge and Cambridgeshire NHS Primary Care Trust (UK)
  Address Research Services Division
University of Cambridge
16 Mill Lane
  City/town Cambridge
  Zip/Postcode CB2 1SB
  Country United Kingdom
  Sponsor website: http://www.rsd.cam.ac.uk/
Date applied 20/12/2007
Last edited 09/07/2012
Date ISRCTN assigned 14/02/2008
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