iDx Lung Health – Developing new tests for the early detection of lung cancer
| ISRCTN | ISRCTN39678730 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39678730 |
| IRAS number | 283721 |
- Submission date
- 05/01/2021
- Registration date
- 03/02/2021
- Last edited
- 11/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-using-blood-samples-and-a-nose-swab-to-detect-lung-cancer-idx-lung
Background and study aims
Lung cancer is the most common cause of cancer-related death worldwide. Survival rates are poor and survival rates over 10 years have not changed over the past 40 years. The majority of patients currently receive a cancer diagnosis once the cancer is in an advanced stage and treatment is not possible. Attempts to improve survival rates in lung cancer are now focussed on early diagnosis and screening. Following a successful pilot study in Manchester, NHS England is rolling out an extended Lung Health Check (scan of the lungs) pilot across 10 sites, including Southampton & Leeds. From mid-2020, a scan will be offered to people between the ages of 55-75 who have ever been smokers.
The aim of this study is to find out whether studying samples of blood or tissue from inside the nose of these patients attending a routine Lung Health Check can help doctors to develop tests to detect lung cancers quicker, leading to faster diagnosis and more effective treatment.
Who can participate?
The researchers are inviting everyone who is having a Lung Health Check in Southampton or Yorkshire to consider taking part. In Southampton patients will be able to take part whether they are referred for a CT scan or not. In Yorkshire they will be able to take part if they are referred for a CT scan.
What does the study involve?
Once participants have signed a consent form online they will undergo a routine Lung Health Check triage test and will either have a low dose CT scan or not as part of the Lung Health Check programme. The study will involve donating a blood sample and a soft brush sample from the nose at the same time as the Lung Health Check. Participants will not be required to attend any further visits for the study.
What are the possible benefits and risks of participating?
It is hoped that this study will improve the Lung Health Check for people in the future by detecting lung cancer earlier. It is uncertain whether this will help patients directly now, but it may help many others in the future. One of the blood tests may suggest there might be something that needs further investigation. If this is the case, the result will be passed on to the Lung Health Checks team so that they can decide whether enrolled subjects need any more tests.
There will be no greater risk than a routine blood test. The taking of blood may sometimes cause discomfort or bruising in the skin and tissue around the vein where blood is taken. Taking a soft brush sample from the nose can cause minimal discomfort. Both will be undertaken by a trained health care professional to minimise any risk.
Where is the study run from?
University of Southampton Clinical Trials Unit (SCTU) (UK)
When is the study starting and how long is it expected to run for?
November 2020 to January 2027
Who is funding the study?
Innovate UK
Who is the main contact?
Darran Ball
idxlung@soton.ac.uk
Contact information
Public
Southampton Clinical Trials Unit (University of Southampton)
Mailpoint 131
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)23 8120 4128 |
|---|---|
| idxlung@soton.ac.uk |
Scientific
Southampton Clinical Trials Unit (University of Southampton)
Mailpoint 131
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)23 8120 4128 |
|---|---|
| idxlung@soton.ac.uk |
Study information
| Study design | Observational biomarker study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Health economic analysis of biomarkers |
| Study setting(s) | Other |
| Study type | Diagnostic |
| Participant information sheet | These will be made available at https://www.southampton.ac.uk/ctu/trialportfolio/listoftrials/idx-lung.page#essential_trial_documentation (will be uploaded after ethical approval) |
| Scientific title | Lung health checks in Wessex and Yorkshire: integrated biomarker studies |
| Study acronym | iDx Lung |
| Study objectives | To determine whether adding blood or tissue biomarkers to low-dose CT scanning improves diagnostic performance in risk-stratified population screening for lung cancer. |
| Ethics approval(s) | Approved 01/04/2021, London - Surrey Research Ethics Committee (Nottingham Centre, The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; +44 (0)207 104 8088, +44 (0)207 104 8102, +44 (0)207 104 8144; surrey.rec@hra.nhs.uk), ref: 21/PR/0211 |
| Health condition(s) or problem(s) studied | Early detection of lung cancer |
| Intervention | This is a prospective cohort study for the collection of blood for autoantibody, protein and nucleic acid biomarkers, and nasal epithelium for transcriptomic analysis from individuals attending for lung health checks at mobile scanners in Wessex and Yorkshire. During the period of the study, individuals undergoing a Lung Health Check will be approached by a member of the clinical team or an appropriately trained member of the research team and asked if they are willing to participate in this study. Consent will be taken and samples obtained in mobile units in convenient community locations, co-located with the clinical evaluation and scanning units of the LHC. No additional clinical data will be collected in the iDx lung biomarker sub-study but biological samples will instead be linked to data collected as part of the main study and all data will be managed by BC platforms. Permissions will also be sought to enable surplus samples to be stored for future research, and for CT scan images to be used for future research. |
| Intervention type | Other |
| Primary outcome measure | Measured using blood and nasal swab samples for biomarker analysis and clinical data routinely collected for the Lung Health Check (TLHC) at a single visit/timepoint when the patient has their CT scan: 1. Calculation of lung cancer risk stratification efficacy of one or any combination of biomarkers independent from or in combination with existing risk models (LLP/PLCOm2012) 2. Calculation of the alteration in diagnostic accuracy by the addition of one or more biomarkers to low dose CT scanning |
| Secondary outcome measures | Measured using blood and nasal swab samples for biomarker analysis and clinical data routinely collected for the Lung Health Check (TLHC) at a single visit/timepoint when the patient has their CT scan: 1. Cost-efficacy changes from the addition of one or more biomarkers to low dose CT scanning 2. Cost-benefit analysis of proposed optimised clinical algorithm |
| Overall study start date | 01/11/2020 |
| Completion date | 31/01/2027 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 7000 |
| Key inclusion criteria | 1. Individuals undergoing a Lung Health Check 2. Ability to understand the study requirements and provide written informed consent |
| Key exclusion criteria | 1. Deemed medically unfit for sample collection 2. Contraindication for study procedures or sampling |
| Date of first enrolment | 01/03/2021 |
| Date of final enrolment | 13/10/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Southampton
SO16 6YD
United Kingdom
Research and Innovation Centre
Beckett Street
Leeds
LS9 7TF
United Kingdom
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
Portsmouth
PO3 6GT
United Kingdom
Sponsor information
Hospital/treatment centre
SGH, Level E, Laboratory & Pathology Block, SCBR, MP 138
Southampton
SO16 6YD
England
United Kingdom
| Phone | +44 (0)23 8120 4989 |
|---|---|
| sponsor@uhs.nhs.uk | |
| Website | http://www.uhs.nhs.uk/home.aspx |
"ROR" |
https://ror.org/0485axj58 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- innovateuk
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | 1. Protocol and other essential documents (PIS, GP letters etc) will be available at https://www.southampton.ac.uk/ctu/trialportfolio/listoftrials/idx-lung.page#essential_trial_documentation 2. The researchers plan to publish in a high-impact peer-reviewed journal by August 2024 |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
11/10/2024: The overall end date was changed from 30/09/2026 to 31/01/2027.
02/10/2023: The following changes have been made:
1. The recruitment end date has been changed from 30/09/2023 to 13/10/2023.
2. The IRAS number has been added.
29/08/2023: The recruitment end date has been changed from 31/08/2023 to 30/09/2023.
11/07/2023: The recruitment end date was changed from 31/07/2023 to 31/08/2023.
12/06/2023: The recruitment end date was changed from 30/06/2023 to 31/07/2023.
14/03/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2023 to 30/06/2023.
2. The overall end date was changed from 31/03/2026 to 30/09/2026.
3. The intention to publish date was changed from 31/03/2026 to 30/09/2026.
4. The plain English summary was updated to reflect these changes.
5. Rodney Road Centre was added as a trial participating centre.
14/07/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/07/2022 to 31/03/2023.
2. The overall end date was changed from 31/08/2023 to 31/03/2026.
3. The intention to publish date was changed from 01/08/2024 to 31/03/2026.
4. The plain English summary was updated to reflect these changes.
5. The target number of participants was changed from 15000 to 7000.
6. The trial participating centre
06/10/2021: The ethics approval has been added.
29/07/2021: Cancer Research UK lay summary link added to plain English summary field.
02/02/2021: Trial's existence confirmed by Innovate UK.
