Plain English Summary
Background and study aims
Melanoma is the most important skin cancer as it can spread and may kill. The numbers of new cases have been increasing substantially in recent years despite public health warnings and advice. The large majority of pigmented moles of the skin are benign but concerns about the possibility of malignancy place a substantial load on primary and secondary health services. Only about 1 in 20 moles referred to specialist dermatologists are shown to be melanoma. The nomela® test is sophisticated software analysing a digital photograph to give an immediate result to provide reassurance to doctor and patient. Approximately 60% of pigmented moles that would have been referred are shown by the test as having no evidence of melanoma. The nomela® test is not a diagnostic test for melanoma but is a screening test which may help the general practitioner or primary care nurse. The aim of this study is to demonstrate that the nomela® test can screen out a significant proportion of pigmented cutaneous lesions as not melanoma from those being referred from primary care to specialist review.
Who can participate?
Adults aged 16 and older who have skin lesions.
What does the study involve?
Participants are asked to participate by the general practitioner/practice nurse if they have presented with a pigmented mole which it has then been decided needs a specialist opinion. Participants are asked to provide written consent after being provided with an information sheet. The doctor or nurse then performs the nomela® test using a dedicated iPad by taking a photograph of the mole. It takes 1 -3 minutes to perform the test. Although the test result is immediately available it is not used in the study to influence the decision to refer. This ends the participation of the patient in the study. The diagnosis made subsequently by the specialist, with or without microscopic examination of any mole removed, is used to check the performance of the nomela® test.
What are the possible benefits and risks of participating?
There are no direct benefits or risks with participating.
Where is the study run from?
This study takes place in NHS Lanarkshire Health and Social Care Partnerships (UK) and Sentinel Health (UK).
When is the study starting and how long is it expected to run for?
April 2017 to October 2018
Who is funding the study?
Moletest (Scotland) Ltd. (UK)
Who is the main contact?
Dr Peter Freedman (Scientific)
Trial website
Contact information
Type
Scientific
Primary contact
Dr Peter Freedman
ORCID ID
http://orcid.org/0000-0002-2282-0646
Contact details
24 Westover Road (2nd floor)
Bournemouth
BH1 2BZ
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
nomela® C5
Study information
Scientific title
A study in primary care of nomela®, an imaging analysis technology, to exclude cutaneous melanoma
Acronym
Study hypothesis
The aim of this study is to demonstrate that the nomela® test can screen out a significant proportion of pigmented cutaneous lesions as not melanoma from those being referred from primary care to specialist review.
Ethics approval
Not provided at time of registration.
Study design
Open single-step non-randomised performance evaluation
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
GP practices
Trial type
Diagnostic
Patient information sheet
See additional files
Condition
Cutaneous melanoma
Intervention
Patients being seen in primary care on whom referral to specialist review has been decided are asked to participate in this study if they satisfy the inclusion criteria and with lesions which satisfy the inclusion criteria.
Participants are given Participant Information Sheets and Consent Forms (with opportunitiy to ask questions, by GP or practice nurse)
After written consent is obtained, the nomela® test is performed using the designated iOS device provided for the study (an iPad on which all other functions have been disabled.
The time to take the nomela® test (identification, location, checking of image) should be less than 3 minutes (with experience 1 minute).
Although the test result is immediately available the decision to refer will not be changed.
This is the end of participation by the patient in the study.
The patient is subsequently seen by the respective specialist dermatologist and managed on routine basis which may include mole removal again on routine basis.
The consent includes access and use of the specialist diagnosis including if performed the histopathology diagnosis.
Intervention type
Device
Phase
Drug names
Primary outcome measure
Sensitivity and specificity is mesaured using statistic analysis.
Secondary outcome measures
Testing the electronic reporting mechanism by nomela® to NHS records.
Overall trial start date
13/04/2017
Overall trial end date
31/10/2018
Reason abandoned (if study stopped)
Research Ethics Committee approval not applied for.
Eligibility
Participant inclusion criteria
1. Patients presenting to primary care for assessment of suspicious pigmented skin lesions AND being referred to Dermatology Departments for specialist review on routine clinical decision.
2. Age 16 years and over. No gender discrimination.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1000
Participant exclusion criteria
1. Other skin conditions considered by the primary care physician not to be pigmenyted moles
2. Patients unable or unwilling to give informed consent.
3. Age less than 16 years.
4. Lesions not suitable for the nomela® test
Recruitment start date
01/03/2018
Recruitment end date
30/09/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
NHS Lanarkshire Health and Social Care Partnerships
ML3 0AA
United Kingdom
Trial participating centre
Sentinel Health
PL6 8BU
United Kingdom
Funders
Funder type
Industry
Funder name
Moletest (Scotland) Ltd.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Peter Freedman (peter.freedman@moletest-scotland.com.
Intention to publish date
31/10/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN15929734_PIS_v3 1BCDE.pdf Uploaded 01/04/2019