At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Colonoscopy (diagnostic test)
- How long the study runs
- Study runs about 24 months (dates as stated)
- About the drug or intervention
- Colonoscopy — diagnostic test: No intervention required from this study, however images will be obtained from patient presenting for colonoscopy
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 4,000
- Started
- 2024-05-04
- Last checked
- 2024-06
Plain English Summary
What is this study?
- • Testing a new treatment for polyp of colon
- • Clinical study - 4,000 participants
- • Accurate classification of growths in the large bowel (polyps) identified during colonoscopy is imperative to inform the risk of colorectal cancer
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with polyp of colon
Where?
- • London - King's College Hospital NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Accurate classification of growths in the large bowel (polyps) identified during colonoscopy is imperative to inform the risk of colorectal cancer. Reliable identification of the cancer risk of individual polyps helps determine the best treatment option for the detected polyp and determine the appropriate interval requirements for future colonoscopy to check the site of removal and for further polyps elsewhere in the bowel. Current advanced endoscopic imaging techniques require specialist skills and expertise with an associated long learning curve and increased procedure time. It is for these reasons that despite being introduced in clinical practice, uptake of such techniques is limited and current methods of polyp risk stratification during colonoscopy without Artificial intelligence (AI) is suboptimal. Approximately 25% of bowel polyps that are removed by major surgery are analysed and later proved to be non-cancerous polyps that could have been removed via endoscopy thus avoiding anatomy altering surgery and the associated risks. With accurate polyp diagnosis and risk stratification in real time with AI, such polyps could have been removed non-surgically (endoscopically). Current Computer Assisted Diagnosis (CADx, a form of AI) platforms only differentiate between cancerous and non cancerous polyps which is of limited value in providing a personalised patient risk for colorectal cancer. The development of a multi-class algorithm is of greater complexity than a binary classification and requires larger training and validation datasets. A robust CADx algorithm should also involve global trainable data to minimise the introduction of bias. It is for these reasons that this is a planned international multicentre study. The Investigators aim to develop a novel AI five class pathology prediction risk prediction tool that provides reliable information to identify cancer risk independent of the endoscopists skill. These 5 categories are chosen because treatment options differ according to the polyp type and future check colonoscopy guidelines require these categories
More detail
The use of artificial intelligence in computer-assisted detection (CADe) to detect polyps (pre-cancerous growths) during colonoscopy is gaining increasing interest and acceptance with multiple devices already in the mainstream market. The Investigator know already from work in other countries that detecting more polyps results in a reduced risk of bowel cancer for the patient having the procedure, in the years following their colonoscopy (ie. pre-cancerous growths were detected and removed). This has formed the basis of national bowel cancer screening programmes. With increased detection of colorectal polyps, there is a growing need to correctly identify the nature of the polyp to inform the risk of colorectal cancer with the polyp detected and also the potential future risk to the patient. Accurate polyp diagnosis is also required to determine the correct mode or removal-whether this does require removal at all (leading to conservation of costs and resources in a challenging current climate), whether endoscopic removal is possible and if so by what procedure, whether surgery is required. Published data demonstrates that approximately one quarter of surgically removed colorectal polyps with patients undergoing major surgery were benign and therefore major surgery could have been avoided with these polyps removed endoscopically reducing the risk of complication and organ preservation for the patient. Current polyp diagnosis techniques involve the use and interpretation of specialist dyes and magnification endoscopes which come with gaining expertise expertise with an associated learning curve and increased procedure time. It is for these reasons that despite being introduced in clinical practice, uptake of such techniques is limited and current methods of polyp risk stratification during colonoscopy without AI is suboptimal. Current polyp diagnosis AI (CADx) algorithms are limited to smaller classification Current CADx platforms differentiate between cancerous and non-cancerous polyps which is of limited value in providing a personalised patient risk for colorectal cancer. The development of a multiclass algorithm is of greater complexity than a binary classification and requires larger training and validation datasets. A robust CADx algorithm should also involve global trainable data to minimise the introduction of bias. It is for these reasons that this is a planned international multicentre study Prospective collection of data: This study will be conducted alongside usual patient care, but will require research staff to enter data onto a secure web-based report form (REDCAP database). This means that participants will undergo exactly the same procedure, with no differences and no extra visits or data, than would have otherwise have occurred. Participants will be those patients that have been scheduled to have a colonoscopy for the standard reasons. Patients will be invited in the usual way for colonoscopy. They may - where possible - be sent the PIS with their appointment letter (up to 6 weeks in advance). On arrival in the endoscopy unit, they will be approached by a member of the research team and given a copy of the PIS to read - up to an hour before their procedure. They will be provided face-to-face information and explanation, prior to written consent to allow their data to be collected in the database. As the study does not require any change or additional procedures, The investigator feel that an initial approach on arrival into the endoscopy unit will provide sufficient, appropriate time to consent, even if the PIS has not been read in advance (although it will be sent if possible). The only additional consideration will be the consent to recording of the video (no patient identifiable data will be transferred as part of this aspect). Once the colonoscopy has been completed, there will be no additional visits.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓\- Above 18 years at inclusion causing symptoms or screening colonoscopy
Who cannot take part
- ✗Unable to provide agreement to take part.
- ✗Colitis Associated Dysplasia
- ✗Polyps at surgical anastomosis sites
- ✗Pregnancy
See the full criteria
Where Is This Study? (1 UK site)
King's College Hospital NHS Foundation Trust
London SE5 9RS, United Kingdom
How to Get in Touch
Shraddha B Gulati, MBBS PHD MRCP
Sponsor contactCONTACT
Olaolu Olabintan, MBBS MRCP
Sponsor contactCONTACT
