Testing nomela® on moles (C8)
| ISRCTN | ISRCTN99987356 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99987356 |
| IRAS number | 254451 |
| Secondary identifying numbers | nomela®C8, IRAS 254451, CPMS 40826 |
- Submission date
- 04/11/2019
- Registration date
- 06/11/2019
- Last edited
- 08/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Suspended
- Condition category
- Cancer
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 September 2022
Who is funding the study?
Moletest (Scotland) Ltd
Who is the main contact?
1. Dr Nigel Burrows
2. Dr Ed Rytina
Contact information
Scientific
24 Westover Road (2nd floor)
Bournemouth
BH1 2BZ
United Kingdom
 ORCID ID |
0000-0002-2282-0646 |
|---|---|
| Phone | +44 (0)1202 702246 |
| peter.freedman@moletest-scotland.com |
Study information
| Study design | Open single-step non-randomized performance evaluation of a medical device |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | ISRCTN99987356_PIS_v2.0_28Mar2019.pdf |
| Scientific title | Testing nomela® on suspicious pigmented naevi (moles): a hospital-based study |
| 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(s) | 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 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | The nomela® test |
| 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 study start date | 03/05/2018 |
| Overall study end date | 15/09/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 completed nomela® tests of pigmented skin lesions confirmed by histopathology as melanoma (all types) |
| Total final enrolment | 1489 |
| 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 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 | 20/06/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cambridge University Hospitals NHS Foundation Trust
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Industry
24 Westover Road (2nd floor)
Bournemouth
BH1 2BZ
United Kingdom
| Phone | +44 (0)1202 702246 |
|---|---|
| joe.ferreira@moletest-scotland.com | |
| Website | www.moletest-scotland.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 15/09/2023 |
|---|---|
| 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 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v2.0 | 28/03/2019 | 08/11/2019 | No | Yes |
| Protocol file | version v3.1 | 05/04/2019 | 08/11/2019 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 11/11/2024 | 08/01/2025 | Yes | No |
Additional files
- ISRCTN99987356_PIS_v2.0_28Mar2019.pdf
- Uploaded 08/11/2019
- ISRCTN99987356_PROTOCOL_v3.1_05Apr2019.pdf
- Uploaded 08/11/2019
Editorial Notes
08/01/2025: Publication reference added.
18/07/2022: The trial has been suspended.
13/07/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/07/2022 to 20/06/2022.
2. The overall trial end date has been changed from 31/07/2023 to 15/09/2022 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 31/01/2024 to 15/09/2023.
4. The final enrolment number has been added.
16/05/2022: The following changes were made to the trial record:
1. The overall end date was changed from 30/11/2022 to 31/07/2023.
2. The intention to publish date was changed from 31/05/2022 to 31/01/2024.
3. The plain English summary was updated to reflect these changes.
12/07/2021: The following changes have been made:
1. The recruitment end date has been changed from 31/07/2021 to 31/07/2022.
2. The overall trial end date has been changed from 30/11/2021 to 30/11/2022 and the plain English summary has been updated to reflect this change.
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.
