A Novel Clinical Decision Support Tool to Predict Submucosal Invasive Cancer Within Large Non-Ped… (NCT07705880) | Clinical Trial Compass
RecruitingNot Applicable
A Novel Clinical Decision Support Tool to Predict Submucosal Invasive Cancer Within Large Non-Pedunculated Colorectal Polyps
Belgium886 participantsStarted 2022-10-01
Plain-language summary
Colorectal cancer can be effectively prevented by removal of pre-malignant polyps during colonoscopy. Large (\>=20mm) non-pedunculated colorectal polyps (LNPCPs) require careful assessment before treatment. If submucosal invasive cancer (SMI) is present, it determines whether endoscopic treatment can be curative or whether surgery is needed. Current classification systems to detect SMI are complex, require extensive training, and are underused in non-tertiary hospitals.
A simple web-based clinical decision support tool was created using well-established parameters (presence of a demarcated area, polyp size, Paris classification, location, and granularity) to identify SMI within LNPCPs. Crucially, the tool uses only standard endoscopic imaging available in most endoscopy units.
This prospective multi-centre study evaluates the accuracy of the tool during live endoscopic assessment. Endoscopists of varying experience will assess 10 large colorectal polyps using the tool, then undergo a randomized educational intervention (either a 10-minute instructional video or a 45-minute interactive training session). They will then assess a further 10 polyps using the tool. A third set of 10 assessments at 3 months evaluates durability of learning. Accuracy is compared to expert opinion.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Endoscopist participants
* Gastrointestinal endoscopists of varying abilities and grades
* Endoscopists who have not previously encountered the clinical decision support tool Patient participants
* Referred for colonoscopy with appropriate bowel preparation
* Colorectal polyp \>=20mm in size detected or referred for resection
* Non-pedunculated morphology
* Non-sessile serrated morphology
* Signed informed consent for the procedure and trial participation
Exclusion Criteria:
Endoscopist participants:
* Does not consent to inclusion
* Does not undergo the learning intervention
* No connection with endoscopy in gastroenterology
Patient participants:
* Does not consent to data collection for the study
* Video of inadequate quality as per opinion of the principal investigator
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Accuracy of Endoscopic Assessment of the Risk of Submucosal Invasive Cancer Within LNPCPs Using the Clinical Decision Support Tool Compared to Expert Opinion During Live Endoscopy
Timeframe: Through study completion, up to 48 months