Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status

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 November 2021 (updated 05/08/2020, previously: December 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



Primary contact

Dr Peter Freedman


Contact details

24 Westover Road (2nd floor)
United Kingdom
+44 (0)1202 702246

Additional identifiers

EudraCT number

Nil known number

Nil known

Protocol/serial number

nomela®C8, IRAS 254451, CPMS 40826

Study information

Scientific title

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



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:, REC ref: 19/EE/0041

Study design

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

Primary study design


Secondary study design

Case series

Trial setting


Trial type


Patient information sheet

Not available in web format


Melanoma in pigmented cutaneous moles


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



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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information


Moletest (Scotland) Ltd

Sponsor details

24 Westover Road (2nd floor)
United Kingdom
+44 (0)1202 702246

Sponsor type




Funder type


Funder name

Moletest (Scotland) Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype


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 ( 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


Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/08/2020: The following changes were made to the trial record: 1. The overall end date was changed from 31/12/2020 to 30/11/2021. 2. The intention to publish date was changed from 30/06/2021 to 31/05/2022. 3. The plain English summary was updated to reflect these changes. 04/08/2020: Recruitment to this study is no longer paused. The recruitment end date was changed from 01/08/2020 to 31/07/2021. 09/04/2020: The overall trial end date was changed from 30/06/2020 to 31/12/2020. 08/04/2020: The recruitment end date was changed from 31/03/2020 to 01/08/2020. Due to current public health guidance, recruitment for this study has been paused. 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.