The MoleMate™ UK Trial: The management of suspicious pigmented lesions in primary care
| ISRCTN | ISRCTN79932379 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79932379 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/12/2007
- Registration date
- 14/02/2008
- Last edited
- 26/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Fiona Walter
Scientific
Scientific
General Practice and Primary Care Research Unit
Institute of Public Health
University Forvie Site
Cambridge
CB2 0SR
United Kingdom
Study information
| Study design | Multi-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Diagnostic |
| Participant information sheet | Participant information sheet: http://www.medschl.cam.ac.uk/gppcru/Projects/MoleMate/downloads.htm |
| Scientific title | The MoleMate™ UK Trial: The management of suspicious pigmented lesions in primary care |
| Study objectives | 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. |
| Ethics approval(s) | Approval received from the Cambridgeshire 2 Research Ethics Committee on the 26th October 2007. REC Reference Number: 07/H0308/167 |
| Health condition(s) or problem(s) studied | Pigmented lesions/ diagnosis of melanoma |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 01/01/2008 |
| Completion date | 30/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1,800 participants from 15 general practices |
| Total final enrolment | 1297 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 30/06/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
General Practice and Primary Care Research Unit
Cambridge
CB2 0SR
United Kingdom
CB2 0SR
United Kingdom
Sponsor information
University of Cambridge and Cambridgeshire NHS Primary Care Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research Services Division
University of Cambridge
16 Mill Lane
Cambridge
CB2 1SB
England
United Kingdom
| Website | http://www.rsd.cam.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/013meh722 |
Funders
Funder type
Government
The NHS National Institute for Health Research (NIHR): School for Primary Care Research (main funder) (UK)
No information available
Biocompatibles UK Limited have supplied the MoleMate systems for the trial.
No information available
Cambridge R & D Consortium - Cambridgeshire Primary Care Trust transitional funding is providing service support for the additional consultations in general practices (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 11/05/2010 | Yes | No | |
| Results article | results | 31/08/2010 | Yes | No | |
| Results article | results | 04/07/2012 | Yes | No | |
| Plain English results | 26/10/2022 | No | Yes |
Editorial Notes
25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
