Condition category
Skin and Connective Tissue Diseases
Date applied
20/12/2007
Date assigned
14/02/2008
Last edited
09/07/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.medschl.cam.ac.uk/gppcru/Projects/MoleMate/

Contact information

Type

Scientific

Primary contact

Dr Fiona Walter

ORCID ID

Contact details

General Practice and Primary Care Research Unit
Institute of Public Health
University Forvie Site
Cambridge
CB2 0SR
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Diagnostic

Patient information sheet

Participant information sheet: http://www.medschl.cam.ac.uk/gppcru/Projects/MoleMate/downloads.htm

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/01/2008

Overall trial end date

30/06/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1,800 participants from 15 general practices

Participant 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

Recruitment start date

01/01/2008

Recruitment end date

30/06/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

General Practice and Primary Care Research Unit
Cambridge
CB2 0SR
United Kingdom

Sponsor information

Organisation

University of Cambridge and Cambridgeshire NHS Primary Care Trust (UK)

Sponsor details

Research Services Division
University of Cambridge
16 Mill Lane
Cambridge
CB2 1SB
United Kingdom

Sponsor type

Government

Website

http://www.rsd.cam.ac.uk/

Funders

Funder type

Government

Funder name

The NHS National Institute for Health Research (NIHR): School for Primary Care Research (main funder) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Biocompatibles UK Limited have supplied the MoleMate systems for the trial.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Cambridge R & D Consortium - Cambridgeshire Primary Care Trust transitional funding is providing service support for the additional consultations in general practices (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Protocol

    Walter FM, Morris HC, Humphrys E, Hall PN, Kinmonth AL, Prevost AT, Wilson EC, Burrows N, Norris P, Johnson M, Emery J, Protocol for the MoleMate UK Trial: a randomised controlled trial of the MoleMate system in the management of pigmented skin lesions in primary care [ISRCTN 79932379]., BMC Fam Pract, 2010, 11, 36, doi: 10.1186/1471-2296-11-36.

  2. Results

    Walter FM, Humphrys E, Tso S, Johnson M, Cohn S, Patient understanding of moles and skin cancer, and factors influencing presentation in primary care: a qualitative study., BMC Fam Pract, 2010, 11, 62, doi: 10.1186/1471-2296-11-62.

  3. Results

    Walter FM, Morris HC, Humphrys E, Hall PN, Prevost AT, Burrows N, Bradshaw L, Wilson EC, Norris P, Walls J, Johnson M, Kinmonth AL, Emery JD, Effect of adding a diagnostic aid to best practice to manage suspicious pigmented lesions in primary care: randomised controlled trial., BMJ, 2012, 345, e4110.

Additional files

Editorial Notes