A study in primary care of nomela® to exclude melanoma
| ISRCTN | ISRCTN15929734 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15929734 |
| Secondary identifying numbers | nomela® C5 |
- Submission date
- 15/01/2018
- Registration date
- 23/01/2018
- Last edited
- 01/04/2019
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Plain English summary of protocol
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)
Contact information
Scientific
24 Westover Road (2nd floor)
Bournemouth
BH1 2BZ
United Kingdom
 ORCID ID |
0000-0002-2282-0646 |
|---|
Study information
| Study design | Open single-step non-randomised performance evaluation |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | GP practice |
| Study type | Diagnostic |
| Participant information sheet | ISRCTN15929734_PIS_v3 1BCDE.pdf |
| Scientific title | A study in primary care of nomela®, an imaging analysis technology, to exclude cutaneous melanoma |
| Study objectives | 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(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 13/04/2017 |
| Completion date | 31/10/2018 |
| Reason abandoned (if study stopped) | Research Ethics Committee approval not applied for. |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 1000 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/03/2018 |
| Date of final enrolment | 30/09/2018 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
United Kingdom
United Kingdom
Sponsor information
Industry
1 Exchange Crescent, Conference Square
Edinburgh
EH3 8UL
United Kingdom
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/10/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v3 | 01/04/2019 | No | Yes |
Additional files
- ISRCTN15929734_PIS_v3 1BCDE.pdf
- Uploaded 01/04/2019
Editorial Notes
01/04/2019: The participant information sheet has been uploaded.
