Condition category
Cancer
Date applied
15/01/2018
Date assigned
18/01/2018
Last edited
06/08/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 (non-cancerous) but concerns about the possibility of malignancy (cancerous) place a large 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. This study aims to provide a significant increase in the number of images of melanoma to support the reference ranges which are used in the software screening process.

Who can participate?
Participants are contacted only to obtain wider consent for this research. The images of their lesions have been taken previously as this in part of the routine care. Participant’s previous consent did not cover the scope of this study. The Pathology department creates lists of provisional cases of confirmed melanoma using the CHI and transfers the list to Medical Illustration who establishes whether they have images of the skin lesions and checks quality. If satisfactory the clinical researcher/dermatologists contacts the patients with a covering letter, participant information sheet and a consent form. After consent is received, the images are tested using the the nomela® test as though they were freshly acquired. The sensitivity of the nomela® test is assessed.

What does the study involve?
There is no direct involvement with participants. Previous images are reviewed using the technology in order for the sensitivity to be measured against reference ranges.

What are the possible benefits and risks of participating?
There are no direct benefits or risks with participating.

Where is the study run from?
University Hospital Monklands (UK)

When is the study starting and how long is it expected to run for?
May 2017 to November 2018

Who is funding the study?
Moletest (Scotland) Ltd (UK)

Who is the main contact?
Dr Peter Freedman

Trial website

Contact information

Type

Scientific

Primary contact

Dr Peter Freedman

ORCID ID

http://orcid.org/0000-0002-2282-0646

Contact details

Moletest (Scotland) Ltd
24 Westover Road (2nd floor)
Bournemouth
BH1 2BZ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Nomela® C7

Study information

Scientific title

Testing of nomela® on images of skin lesions confirmed as cutaneous melanoma

Acronym

Study hypothesis

The aim of this study is to increase confidence in the ranges used by nomela® as a screening test to exclude melanoma in suspicious pigmented moles by evaluating historic images of lesions confirmed as cutaneous melanoma.

Ethics approval

West of Scotland REC 5, 24/04/2018

Study design

Retrospective non-randomised cohort study single study performance evaluation

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

See additional files

Condition

Cutaneous melanoma

Intervention

There is no direct involvement of participants. In effect there is no enrolment nor participation except that participants are being asked to widen the scope of consent so that the use of images of the skin lesions which were taken in the course of routine clinical practice in the period defined (and which predates the performance of the study) encompasses this specific research. The "duration of observation" is an instant and there is no follow-up. There is no feedback as clinical care is not affected.

Participants are contacted only to obtain wider consent for this research. The images of their lesions already exists as this in part of the routinue clinical pathway that the NHS Lanarkshire has used for several years. The previous consent did not cover the scope of theis research. The Pathology department creates lists of provisional cases of confirmed melanoma using the CHI and transfers the list to Medical Illustration who establishes whether they have images of the skin lesions and checks quality. If satisfactory the clinical researcher/dermatologists contacts the patients with a covering letter, participant information sheet and a consent form. After consent is received, the images are tested using the the nomela® test as though they were freshly acquired.

Intervention type

Device

Phase

Drug names

Primary outcome measure

Sensitivity is measured against reference ranges defined in previous range-finding study (Moletest004) note that specificity will not be available in this study.

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

31/05/2017

Overall trial end date

30/11/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age 16 years and over
2. Having a confirmed diagnosis of cutaneous melanoma in NHS Lanarkshire

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

At least 80

Participant exclusion criteria

1. Unable or unwilling to give informed consent
2. Aged less than 16 years

Recruitment start date

02/08/2018

Recruitment end date

31/10/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital Monklands
Department of Pathology
Airdrie
ML6 0JS
United Kingdom

Sponsor information

Organisation

Moletest (Scotland) Ltd.

Sponsor details

1 Exchange Crescent
Conference Square
Edinburgh
EH3 8UL
United Kingdom

Sponsor type

Industry

Website

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 not expected to be made available as the dataset is to confirm ranges used by the nomela® test. The information is held by Moletest (Scotland) Ltd.

Intention to publish date

30/11/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/08/2018: The following changes were made to the trial record: 1. The ethics approval details were added. 2. The recruitment start date was changed from 01/02/2018 to 02/08/2018. 3. The recruitment end date was changed from 31/03/2018 to 31/10/2018. 4. The overall trial end date was changed from 31/05/2018 to 30/11/2018.