Providing data so computer systems can help with the early identification of lung diseases, leading to more rapid treatment and better survival rates
ISRCTN | ISRCTN13720905 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN13720905 |
IRAS number | 301420 |
Secondary identifying numbers | PID15885-A002-SP001, IRAS 301420, CPMS 51308 |
- Submission date
- 03/03/2022
- Registration date
- 07/04/2022
- Last edited
- 05/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-to-develop-and-test-a-computer-programme-to-help-to-improve-the-diagnosis-of-lung-cancer#undefined (added 05/05/2022)
Background and study aims
In the UK, lung cancer is common with a very low 5-year survival rate as most patients are diagnosed at a late stage. Early detection on a CT scan when the cancers are small and seen as a nodule has been shown to improve survival.
DART will work with NHS England’s ambitious Lung Cancer Screening programme using CT to collect clinical, CT and histology data for research aimed at improving lung cancer diagnosis and screening using artificial intelligence, AI.
If DART is successful, using artificial intelligence we will speed up the time to diagnose lung cancer whilst also identifying incidental harmless nodules on CT. DART aims to: remove the need for other investigations such as lung biopsies, making investigations safer and quicker; help pathologists diagnose lung cancer using; help patients by providing their doctors with more information on lung and heart function; improve patient selection for lung cancer screening.
DART aims to improve screening using AI, resulting in the avoidance of additional tests and biopsies which cause great patient anxiety, take time and are expensive.
DART will develop an AI algorithm for histology so that specimens from lung biopsies and resections can also be analysed in a similar fashion to CT scans.
Patients with lung cancer often have damaged lungs from smoking making surgery or radiation treatment unsafe. DART plans to develop an AI technique that can be used on all lung CT scans performed. As smoking can cause heart disease, patients screened for lung cancer often have heart disease. DART aims to use AI to see if we can identify this from their CT scans.
We will develop a specific risk model for Lung Cancer Screening selection, that outperforms published risk models that have been developed in academic institutions but are not used in clinical practice.
Who can participate?
To aid our research, it is important to gather data from as many people attending Lung Health Checks as possible. However, if you do not want your data included, now or at any time, please tell us using the contact details below
What does the study involve?
Computers will be to conduct additional analysis of scans and data from those attending lung health checks. It will not require any extra time or visits and will not interfere in any way with the standard health care.
Personal information will be kept private, but an NHS research laboratory will be able to link a patient’s your data (health records, scans, biopsies and resections) accurately.
What are the possible benefits and risks of participating?
There are no health risks to participating. We will anonymise data by removing the code before it is used by researchers so there is no link back to patients, who will never be identified in research or publications.
There are no immediate benefits to participants, but participation will contribute towards:
• If found at an early stage, lung cancer is curable
• DART will develop an Artificial Intelligence software programme that is faster and accurate to assist doctors to interpret CT scans and detect cancer
• This will speed up the time to diagnosis and reduce the numbers of additional scans and biopsies that might be needed in future.
• As smoking can cause heart disease, patients screened for lung cancer often have heart disease, and we aim to use AI to see if we can identify this from their CT scans as well.
Where is the study run from?
The study is run from the University of Oxford (UK)
When is the study starting and how long is it expected to run for?
Data will be collected from lung health checks between 1st October 2020 and 31st July 2023
Who is funding the study?
The study is funded by UK Research and Innovation
Who is the main contact?
Prof Fergus Gleeson, Professor of Radiology, University of Oxford, fergus.gleeson@oncology.ox.ac.uk
Contact information
Principal Investigator
Department of Oncology
University of Oxford
Old Road Campus
Research Building
Oxford
OX3 7DQ
United Kingdom
0000-0002-5121-3917 | |
fergus.gleeson@oncology.ox.ac.uk |
Study information
Study design | Retrospective data collection |
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Primary study design | Other |
Secondary study design | |
Study setting(s) | Community |
Study type | Other |
Participant information sheet | https://dartlunghealth.co.uk/patients/ see Downloadable documents |
Scientific title | The integration and analysis of Data using Artificial intelligence to impRove patient outcomes with Thoracic diseases |
Study acronym | DART |
Study hypothesis | To develop an artificial intelligence prediction model for malignancy in pulmonary nodules detected on CT scans based on nodule characteristics including histology, and patient clinical risk profiles using machine deep learning models. |
Ethics approval(s) | Approved 24/02/2022, West Midlands - Black Country Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham NG1 6FS; +44 (0)207 104 8010; blackcountry.rec@hra.nhs.uk), ref: 21/WM/0278, CAG 22/CAG/0010 |
Condition | Early diagnosis of lung cancer |
Intervention | Data will be collected retrospectively from Lung Health Check centres, with patient consent. There will be no impact on patient care. |
Intervention type | Other |
Primary outcome measure | 1. Diagnosis of cancer measured by expert opinion using Targeted Lung Health Check spreadsheets and CT scans, collected from patients attending lung health checks first visit. 2. Diagnosis of cancer measured by AI model using Digital images collected from the CT scan. |
Secondary outcome measures | 1. Diagnosis of cancer determined by expert histology opinion from resection and biopsy specimens 2. Diagnosis of cancer determined by the AI model from the digitised resection and biopsy specimens |
Overall study start date | 01/10/2020 |
Overall study end date | 31/07/2023 |
Eligibility
Participant type(s) | Mixed |
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Age group | Adult |
Sex | Both |
Target number of participants | 300,000 |
Participant inclusion criteria | Participants attending NHSE targeted lung health checks |
Participant exclusion criteria | Patients who request to not be included in any studies as part of the NHS opt out. |
Recruitment start date | 01/10/2020 |
Recruitment end date | 31/07/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Oxford
OX3 7DQ
United Kingdom
Chorley
PR7 1PP
United Kingdom
BD9 6RJ
United Kingdom
Liverpool
L14 3PE
United Kingdom
Kettering
NN16 8UZ
United Kingdom
Coventry
CV2 2DX
United Kingdom
Armthorpe Road
Doncaster
DN2 5LT
United Kingdom
Hull
HU3 2JZ
United Kingdom
Luton
LU4 0DZ
United Kingdom
London
SW3 6NP
United Kingdom
Salford
M6 8HD
United Kingdom
Stoke-on-trent
ST4 7LN
United Kingdom
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Sherriff Hill
Gateshead
NE9 6SX
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor information
University/education
Joint Research Office
1st floor, Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
England
United Kingdom
ctrg@admin.ox.ac.uk | |
Website | https://www.ukri.org/ |
https://ror.org/001aqnf71 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- UKRI
- Location
- United Kingdom
Results and Publications
Intention to publish date | 30/09/2023 |
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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 | De-identified data will be shared with academic and industrial partners as approved by the CI |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
HRA research summary | 28/06/2023 | No | No |
Editorial Notes
05/05/2022: Internal review.
05/05/2022: The Cancer Research UK plain English summary has been added.
20/04/2022: The ethics approval has been added.
04/03/2022: Trial's existence confirmed by the NHS HRA