Rapid screening of cheek cells to distinguish cancer using light
| ISRCTN | ISRCTN18176235 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18176235 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 257831 |
| Protocol serial number | IRAS 257831, CPMS 41596 |
| Sponsor | Sierra Medical |
| Funders | Sierra Medical, Innovate UK |
- Submission date
- 09/09/2022
- Registration date
- 21/10/2022
- Last edited
- 28/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Non-small cell lung cancer (NSCLC) is the UK’s leading cause of cancer deaths. Early diagnosis of lung cancer is key to improving survival rates. Most patients aren’t diagnosed until stage 4, when a cure is often not possible. Sierra Medical are developing a new and unique non-invasive screening test to detect NSCLC from a simple cheek swab with extremely high accuracy. To get the technology approved for use in hospitals, they need to conduct a series of clinical trials. This is the first clinical trial required to gain approval.
Who can participate?
1. Non-smokers with no history of lung disease
2. Current or ex-smokers with no history of lung disease
3. Current or ex-smokers with confirmed COPD
4. Current or ex-smokers with lung cancer (NSCLC only)
5. Smokers and non-smokers with other types of lung cancer
All aged 18 years and over
What does the study involve?
Participants will be seen in a research clinic where medical history will be obtained, lung function tests are performed and two cheek swabs are taken. These swabs will be analysed to demonstrate that there is a difference between cells from patients with and without lung cancer.
What are the possible benefits and risks of participating?
There will be no immediate benefit to the participant. However, if the study is successful participants will contribute to developing a lung cancer screening test that will enable earlier detection of lung cancer which will provide better outcomes to future lung cancer patients. The participant will be paid £10 to cover time and travel. There are very few risks associated with participation in the study, however, the participant may experience temporary irritation to the inside of their cheek where they were swabbed and/or temporary dizziness from forced exhalation during the lung function test (spirometry). Both side effects are rare and temporary.
Where is the study run from?
Queen Alexander Hospital (UK)
When is the study starting and how long is it expected to run for?
March 2019 to June 2024
Who is funding the study?
1. Innovate UK
2. Sierra Medical Ltd (UK)
Who is the main contact?
Thomas.macdonald@porthosp.nhs.uk
Contact information
Principal investigator
Portsmouth Hospitals NHS Trust
Queen Alexandra Hospital
Southwick Hill Road
Cosham
PO6 3LY
United Kingdom
| Phone | +44 (0)2392286000 |
|---|---|
| anoop.chauhan@porthosp.nhs.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational study |
| Secondary study design | |
| Study type | Participant information sheet |
| Scientific title | Infrared analysis of buccal cell swabs as a novel non-invasive screening test for lung cancer in individuals exposed to carcinogens |
| Study acronym | RADiCAL |
| Study objectives | Infrared (IR) fingerprints collected using lab-based IR micro-spectroscopy of individual human buccal mucosa cells can be used to differentiate between smokers with non-small cell lung cancer (NSCLC) and smokers/non-smokers without NSCLC with sufficient accuracy to be used as an initial screening test for lung cancer. |
| Ethics approval(s) | Approved 20/03/2019, South Central - Berkshire Research Ethics Committee (Bristol REC Centre, Whitefriars, Level 3, Block B Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)20 7104 8057; berkshire.rec@hra.nhs.uk), ref: 19/SC/0100 |
| Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease (COPD) and/or non-small cell lung cancer |
| Intervention | Patients will attend one study visit where the following will be obtained/performed: 1. Informed consent 2. Specific medical history 3. Brief medical history 4. Smoking history 5. Assessment of food and other potential contaminates 6. Collection of cheek swabs 7. Lung function test (spirometry) 8. Confirm eligibility 9. Record adverse events 10. Acceptability questionnaire |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Sierrra AIR-DS |
| Primary outcome measure(s) |
Individual infrared (IR) spectra collected from each participant's cheek cells using a Fourier-transform infrared spectroscopy (FTIR) microspectrometer at a single timepoint |
| Key secondary outcome measure(s) |
Average IR spectra of buccal mucosa swabs measured using a benchtop ATR-FTIR spectrometer for smokers with NSCLC and smokers/non-smokers without NSCLC at a single timepoint |
| Completion date | 30/06/2024 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 700 |
| Key inclusion criteria | There are five arms of the study. Approximately 100 participants will be recruited into the following four groups: A. Non-smokers with no history of lung disease B. Current or ex-smokers with no history of lung disease C. Current or ex-smokers with confirmed COPD D. Current or ex-smokers with lung cancer An additional exploratory group of up to 50 participants will be recruited: E. Smokers and non-smokers with heterogenous lung cancers or suspected lung cancer 1. Are able to understand and provide signed consent – All groups 2. Are aged 18 years or older – All groups 3. Are able to provide a cheek swab sample – All groups 4. Are a non-smoker and never used e-cigarettes – Group A only 5. Are a smoker or ex-smoker – Group B, C and D 6. Must have spirometry of FEV1/FVC ratio >0.7 - Group A and B 7. Are diagnosed with COPD and meet the GOLD criteria for COPD (post-bronchodilator airway obstruction with FEV1/FVC ratio <0.7) Group C only 8. Have (or eventually proven to have) a histologically-confirmed primary non-small cell lung cancer - Group D only 9. Have not commenced treatment for non-small cell lung carcinoma - Group D only 10. Have (or eventually have) a histologically-confirmed cancer a) other than a NSCLC (e.g. small-cell cancer, carcinoid) or b) NSCLC but have never smoked or c) NSCLC but have received treatment – Group E only |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 01/05/2019 |
| Date of final enrolment | 30/06/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Portsmouth
PO6 3LY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to commercial sensitivity |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/02/2024: The following changes were made to the trial record:
1. The overall end date was changed from 31/01/2022 to 30/06/2024.
2. The recruitment end date was changed from 31/01/2022 to 30/06/2024.
3. The target number of participants was changed from 400 to 700.
4. The plain English summary was updated to reflect these changes.
01/11/2022: Internal review.
20/10/2022: Trial's existence confirmed by the South Central - Berkshire Research Ethics Committee.
