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| The MoleMate™ UK Trial: The management of suspicious pigmented lesions in primary care |
| Source of record | UK Trials |
| ISRCTN | ISRCTN79932379 |
| Date ISRCTN assigned | 14/02/2008 |
| Local reference number(s) | N/A |
| Public title | The MoleMate™ UK Trial: The management of suspicious pigmented lesions in primary care |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Pigmented lesions/ diagnosis of melanoma |
| 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. |
| Design/methodology | Multi-centre randomised controlled trial |
| Research ethics review | Approval received from the Cambridgeshire 2 Research Ethics Committee on the 26th October 2007. REC Reference Number: 07/H0308/167 |
| Countries of trial | United Kingdom |
| 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 |
| Patient information material | Participant information sheet: http://www.medschl.cam.ac.uk/gppcru/Projects/MoleMate/downloads.htm |
| Anticipated start date | 01/01/2008 |
| Anticipated end date | 30/06/2010 |
| Status of trial | Ongoing |
| 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 |
| Trial website | http://www.medschl.cam.ac.uk/gppcru/Projects/MoleMate/ |
| Sources of funding | 1. The NHS National Institute for Health Research (NIHR): School for Primary Care Research (main funder) (UK) 2. Astron Clinica will fund the development of the training programme and provide the MoleMate systems for the trial (UK) 3. Cambridge R & D Consortium - Cambridgeshire Primary Care Trust transitional funding is providing service support for the additional consultations in general practices (UK) |
| Sponsor name | University of Cambridge and Cambridgeshire NHS Primary Care Trust (UK) |
| Sponsor details | Research Services Division University of Cambridge 16 Mill Lane Cambridge United Kingdom CB2 1SB |
| Sponsor website | http://www.rsd.cam.ac.uk/ |
| Contact name | Dr Fiona Walter |
| Contact details | General Practice and Primary Care Research Unit Institute of Public Health University Forvie Site Cambridge United Kingdom CB2 0SR |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN79932379 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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