Condition category
Cancer
Date applied
04/11/2019
Date assigned
06/11/2019
Last edited
08/11/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Most skin moles are not serious but an important small number are serious (melanoma). The load on health services from moles with a suspicion of malignancy is substantial yet many moles referred to hospital are considered benign on inspection by the specialist. However, some moles require a skin biopsy to clarify the diagnosis. This study will check the performance of nomela®, a photographic image analysis test using tablet software technology, which aims to assist in the exclusion of melanoma. If nomela® is shown to work well it would be used to reduce the need for referral for a skin biopsy.

Who can participate?
Patients with a pigmented mole which the specialist has decided on routine clinical grounds to have removed for a specialist pathology opinion

What does the study involve?
When the specialist has decided to arrange for a biopsy of the mole or for the mole to be removed the routine practice is to have photographs taken of the mole(s) by the Media Studio photographers. The only extra activity over the routine is that participants have nomela® test photographs taken of their mole in this clinic by the nurse using a specially prepared iPad: this lasts a few minutes. Their routine care is not affected.

What are the possible benefits and risks of participating?
There will be no direct benefit to participants at present. However, if the nomela® test is found to be fit for purpose then specialist dermatologists/plastic surgeons and general practitioners will support its wider use. There is very little risk associated with taking part in the study. Whether patients take part or not in the study, the specialist has considered that biopsy or removal of the mole is needed. This will be explained separately and a separate consent will be requested. The risk of exposure of personal data is minimised as follows. The patient’s hospital number is only shown on the electronic consent form. This is immediately transferred securely from the device to a dedicated research NHS email which is only available to the specialist doctor and the dedicated clinical research team. No personal or test information of any kind is kept on the nomela® device on completion of the test and its transfer. The hospital number is encrypted securely on the Moletest server only for linkage to the diagnosis of the skin biopsy by the clinical research team but cannot be discovered by anyone other than the specialist doctor and dedicated clinical research team. The results of this study will be published in suitable medical journals and presentations may be made at relevant medical conferences. Under no circumstances will patients’ names or other personal details be revealed. Participants will be able to request a summary of the results of the study from the Dermatology Department, Addenbrooke’s Hospital if they wish.

Where is the study run from?
Cambridge University Hospitals NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
September 2019 to March 2020

Who is funding the study?
Moletest (Scotland) Ltd

Who is the main contact?
1. Dr Nigel Burrows
2. Dr Ed Rytina

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
+44 (0)1202 702246
peter.freedman@moletest-scotland.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

nomela®C8; IRAS: 254451

Study information

Scientific title

Testing nomela® on suspicious pigmented naevi (moles): a hospital-based study

Acronym

nomela®C8

Study hypothesis

1. To measure the performance of the nomela® test as a risk calculator for melanoma in pigmented skin lesions of patients referred by specialists for biopsy/excision and histopathology.
2. To demonstrate that the nomela® test provides at least 95+/- 2 % sensitivity for not-melanoma.

Ethics approval

Approved 11/04/2019, East of England - Cambridge Central Research Ethics Committee (Royal Standard Place, Nottingham, NG1 6FS, UK; Tel: +44 (0)207 104 8101; Email: NRESCommittee.EastofEngland-CambridgeCentral@nhs.net), REC ref: 19/EE/0041

Study design

Open single-step non-randomised performance evaluation of a medical device

Primary study design

Observational

Secondary study design

Case series

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format

Condition

Melanoma in pigmented cutaneous moles

Intervention

The nomela® test, a technology for capturing digital images of skin lesions and making an analysis by signal-processing. nomela® test output to be compared with histopathology result.
Total duration of observation: 5 minutes for the single nomela® test.
No determination of clinical decision.
No follow-up.
Histology diagnosis collected within 12 weeks.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measure

Sensitivity (95% CI) of the nomela® test for not-melanoma. Measured at a single timepoint.

Secondary outcome measures

The proportion (95% CI) of lesions that the nomela® test finds as having 'no evidence of melanoma'. Measured at a single timepoint.

Overall trial start date

03/05/2018

Overall trial end date

30/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patients referred on routine clinical decision by the Dermatology/Plastic Surgery Departments for biopsy/excision biopsy and histopathology of suspicious pigmented skin lesions

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200 completed nomela® tests of pigmented skin lesions confirmed by histopathology as melanoma (all types)

Participant exclusion criteria

1. Other skin conditions not considered to be pigmented moles
2. Lesions not considered suitable for nomela®: pigmented moles smaller than 5mm diameter; moles obscured by hair, scar or tattoos; moles in the mouth, eyelid, nailbed, genital and perianal areas; ulcerated lesions; non-pigmented moles which may be the amelanotic form of melanoma; lesions likely to be basal cell carcinoma, squamous cell carcinoma, Merkel cell tumours, lymphoma, metastatic carcinoma
3. Patients unable or unwilling to give informed consent
4. Patients aged less than 16 years

Recruitment start date

09/09/2019

Recruitment end date

31/03/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Dermatology
Box 46 Cambridge University Hospitals NHS Foundation Trust Cambridge Biomedical Campus Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Moletest (Scotland) Ltd

Sponsor details

24 Westover Road (2nd floor)
Bournemouth
BH1 2BZ
United Kingdom
+44 (0)1202 702246
joe.ferreira@moletest-scotland.com

Sponsor type

Industry

Website

www.moletest-scotland.com

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 will be available upon request from Bruce Murray, Technical Director (bruce.murray@moletest-scotland.com). Type of data: the nomela® test analysis result (text) and histology result (diagnosis). When the data will become available and for how long: at overall trial end; not specified, ?3 years. By what access criteria data will be shared including with whom: not specified. For what types of analyses: not specified. By what mechanism: online after email enquiry. Whether consent from participants was obtained: consent for research use of anonymised data obtained from participants. Comments on data anonymisation: hash-one-way encryption hospital number means not available except to clinical team; the number is expunged from the dataset on entry of histology diagnosis category i.e before overall trial end.

Intention to publish date

30/06/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

08/11/2019: Uploaded protocol Version 3.1, 05 April 2019 (not peer reviewed). The participant information sheet has been uploaded 05/11/2019: Trial's existence confirmed by ethics committee.