Future of real time endoscopy, artificial intelligence
| ISRCTN | ISRCTN15467766 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15467766 |
| IRAS number | 271876 |
| Secondary identifying numbers | SPON 1781-19, IRAS 271876 |
- Submission date
- 23/02/2024
- Registration date
- 23/02/2024
- Last edited
- 23/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
This study is a substudy of the CONSCOP2 study (https://www.isrctn.com/ISRCTN98539180).
Odin Medical has developed a Computer Assisted Detection and Diagnosis system for colonoscopy. The system acts like a second pair of eyes during the procedure using artificial intelligence (AI) to find/analyse polyps in colonoscopy images.
The AI solution works with existing hospital equipment. It sends the colonoscopy image from the hospital to a secure cloud/super-computer where they are analysed.
The aim of this project is to demonstrate the benefits of using AI in colonoscopy through a multicentre randomised controlled trial. These benefits include, better patient outcomes by improving polyp/cancer detection rates, improved patient experience with instant diagnosis and increased operational efficiency. The project will gather clinical data and perform health economic analyses.
Who can participate?
CONSCOP2 participants will be approached for additional optional consent to participate in the FORE-AI sub-study.
What does the study involve?
Participants will have the colonoscopy as usual, however some will be analysed using AI, and others by the colonoscopist, in order to evaluate AI performance. This will not affect the standard care of the participants in any way.
What are the possible benefits and risks of participating?
By participating in bowel screening, all participants will already have taken steps to detect polyps and consequently reduce their risk for future bowel cancer. If allocated to the dye spray group, more polyps may be detected and removed that could have turned into cancer, which further minimises the risk of future bowel cancer. However, the colonoscopy with dye spray will take on average 6 minutes longer than usual, especially if extra polyps are found, and there may be an increased risk of complications (e.g. bleeding if polyps found are removed) although we believe this to be very unlikely. Additionally, there is the chance that the extra polyps remove may never have turned into cancer.
For all participants, the main benefits of the study will be to inform UK bowel cancer screening programmes in the future as to whether the using dye spray during colonoscopies helps in the detection of serrated polyps and possibly prevention of bowel cancers.
The blue dye used within the interventional arm is a safe food colouring agent and is already used routinely in various endoscopy procedures in standard clinical practice. Extremely rarely there may be individuals with a specific allergic response to this in the past. For this reason, anyone with a known allergy to a food colouring agent will be excluded from taking part in the study.
Where is the study run from?
The trial team are based in the Centre for Trials Research (CTR) at Cardiff University. Overall, the researchers plan that 25 centres in total across Wales, England and Scotland will participate in the recruitment for the trial. The lead centre will be Llandough Hospital (Cardiff & Vale University Health Board) as this is the site where the Chief Investigator, Dr Sunil Dolwani, is based.
When is the study starting and how long is it expected to run for?
June 2021 to July 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Georgina Gardner
CONSCOP2@cardiff.ac.uk
Contact information
Public, Scientific, Principal Investigator
Centre for Trials Research
College of Biomedical & Life Sciences
Cardiff University
6th Floor, Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
 ORCID ID |
0000-0001-5886-8185 |
|---|---|
| Phone | +44 29 20687950 |
| CONSCOP2@cardiff.ac.uk |
Study information
| Study design | Observational randomised controlled |
|---|---|
| Primary study design | Observational |
| Secondary study design | randomised controlled |
| Study setting(s) | Hospital |
| Study type | Diagnostic, Screening, Efficacy |
| Participant information sheet | 45093 PIS v1 17Nov2020.pdf |
| Scientific title | Future of Real Time Endoscopy, Artificial Intelligence (substudy of CONSCOP2) |
| Study acronym | FORE AI |
| Study objectives | FORE AI is a separately funded study that will be conducted on a subset of CONSCOP2 (https://www.isrctn.com/ISRCTN98539180) participants. The project is led by Odin Vision a trading name of Odin Medical Limited and will be conducted in collaboration with the CONSCOP2 trial team, Cardiff University Division of Population Medicine, CTR, Aquarius Population Health, and the Bowel and Cancer Research Charity. The study will investigate the use of artificial intelligence to analyse real time colonoscopy videos during screening colonoscopy as part of the bowel cancer screening program in sites throughout England and Wales to improve the detection of and diagnosis of polyps. This will collect prospective video data only and will not affect the standard care of the participants in any way. |
| Ethics approval(s) |
Approved 18/01/2021, Wales REC6 (c/o Public Health Wales Building 1 Jobswell Road St David’s Park, Swansea, SA31 3HB, United Kingdom; +44 1267 61 1164; Wales.REC6@wales.nhs.uk), ref: 20/WA/0019 |
| Health condition(s) or problem(s) studied | Bowel/colorectal cancer |
| Intervention | The CADDIE system will be deployed to collect video and histopathology data from patients randomised to high-definition white light colonoscopy with or without Indigo Carmine dye spray and with AI (colonoscopists all high detectors and blinded to AI results at the time of the procedure) (part of the CONSCOP2 study https://www.isrctn.com/ISRCTN98539180). The results from the AI annotated group will be compared to the colonoscopist detection and with histopathology. During a standard colonoscopy procedure, the colonoscope transmits video data to a monitor for the attending physician's examination, aiming to identify polyps in the patient's colon. Permission is sought from the individual to utilize a recording of this video in real time for the purpose of advancing new technological developments. It is emphasised that this request does not impact the colonoscopy procedure itself. The goal is to enhance future technology that can assist doctors in more accurately detecting polyps and providing instant diagnoses. Any polyps removed during the colonoscopy are forwarded to a pathologist for diagnosis |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Detection and diagnosis of polyps using a video of the procedure will be compared between the AI software and the colonoscopists to assess the accuracy of the AI. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 10/06/2021 |
| Completion date | 07/07/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 56 Years |
| Upper age limit | 74 Years |
| Sex | Both |
| Target number of participants | 1000 |
| Total final enrolment | 1002 |
| Key inclusion criteria | In the participating FORE AI sites, all CONSCOP2 (https://www.isrctn.com/ISRCTN98539180) participants will be approached for additional optional consent to participate in the FORE-AI sub-study via the CONSCOP2 main PIS/ICF. |
| Key exclusion criteria | 1. Previous resectional colorectal surgery (as this would influence both study methods and outcomes depending on the length of residual colon in the individual) 2. Any participants not deemed fit for colonoscopy on the screening program or undergoing alternative investigation such as CT pneumocolon or minimal prep CT scan as their index procedure instead. 3. Known allergy to food colouring agent (as the Indigo Carmine dye is a safe food colouring agent but extremely rarely there may be individuals with a specific allergic response to this in the past). 4. Previous inclusion in trial |
| Date of first enrolment | 23/07/2021 |
| Date of final enrolment | 07/07/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Penrhosgarnedd
Bangor
LL57 2PW
United Kingdom
Hafan Derwen
St Davids Park, Jobswell Road
Carmarthen
SA31 3BB
United Kingdom
Maes-y-coed Road
Cardiff
CF14 4HH
United Kingdom
DEWI SANT HOSPITAL
ALBERT ROAD
PONTYPRIDD MID GLAMORGAN.
CF37 1LB
Pontypridd
CF37 1LB
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Sandford Road
Cheltenham
GL53 7AN
United Kingdom
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
Sponsor information
University/education
Research Governance Coordinator Research and Innovation Services Cardiff University
7th Floor, McKenzie House
30-36 Newport Rd
Cardiff
CF24 0DE
Wales
United Kingdom
| Phone | +44 29208 79130 |
|---|---|
| ShawC3@cardiff.ac.uk | |
| Website | http://www.cardiff.ac.uk/ |
"ROR" |
https://ror.org/03kk7td41 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Applied Research Collaboration East of England, NIHR ARC East of England, ARC East of England, NIHR Applied Research Collaboration East of England, NIHR Applied Research Collaboration (ARC) North East, National Institute for Health Research (NIHR) Applied Research Collaboration (ARC), ARC EoE, NIHR ARC EoE
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/07/2025 |
|---|---|
| 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 | Results published in high impact journals and at patient events |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1 | 17/11/2020 | 23/02/2024 | No | Yes |
| Protocol file | version 4 | 17/11/2020 | 23/02/2024 | No | No |
Additional files
Editorial Notes
23/02/2024: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
