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Early DiAgnosis Real-Time Healthcare System for CANcer Trial

This study is testing a new artificial intelligence (AI) system, called CADDIE, to help doctors during a colonoscopy. A colonoscopy is a procedure where a camera is used to look inside your bowel. Sometimes, small growths called polyps are found. The CADDIE system uses AI to help the doctor identify these polyps more accurately. Participants will either have their colonoscopy with the CADDIE system helping the doctor, or they will have a standard colonoscopy without the CADDIE system. The main goal is to see if CADDIE improves how well doctors can tell what kind of polyps they are seeing. This could potentially help in making quicker decisions about treatment.

At a glance

Status
Recruiting
Sponsor
University College, London
Enrolment target
420
Start
18 Jul 2024
Estimated completion
01 May 2025

What is this study about?

This study is called the Early DiAgnosis Real-Time Healthcare System for CANcer Trial, or CADDIE for short. It's looking into a new way to help doctors find and understand growths, called polyps, inside your bowel during a common procedure called a colonoscopy. Polyps are small lumps that can grow on the lining of your bowel, and while many are harmless, some can turn into cancer over time. Being able to accurately identify these polyps is really important.

The CADDIE system uses special computer technology, known as Artificial Intelligence (AI). Think of it like a smart assistant that helps the doctor. While the doctor is performing the colonoscopy, the CADDIE system is connected to the camera that looks inside your bowel. It helps to highlight the features of any polyps it sees. This information pops up on a screen to help the doctor make a better and quicker decision about what the polyp might be, even just by looking at it.

To find out if CADDIE is helpful, some people in the study will have their colonoscopy with the CADDIE system switched on, actively helping the doctor. Other people will have a standard colonoscopy, where the CADDIE system is present but not actively assisting. This helps the researchers compare how well doctors perform with and without the AI helper. The aim is to see if this new AI technology can improve how precisely doctors identify polyps, which could lead to better and faster care for patients.

Key takeaways

  • The study tests an AI system (CADDIE) to help doctors during colonoscopies.
  • It aims to improve accurate identification of bowel polyps.
  • You'll have a standard colonoscopy, either with or without CADDIE helping the doctor.
  • No extra tests or visits are required beyond your planned colonoscopy.
  • Participation helps future patients by potentially improving detection methods.

Who may be eligible?

To take part in this study, you need to be at least 18 years old and scheduled to have a colonoscopy. This could be a routine check-up, a follow-up for a previous issue, or if you're having symptoms. You also need to be able to understand and sign the consent form to show you agree to be in the study.

There are certain reasons why you wouldn't be able to join. For example, if you need an emergency colonoscopy or if you are already in hospital. You also can't take part if you have certain bowel conditions like inflammatory bowel disease (IBD), currently have bowel cancer, or if you have certain bleeding problems or are taking medicines that might make you bleed more during the procedure. It's also not suitable if you're already in another study testing a new drug or treatment that might affect bleeding.

Quick self-check
  • Are you 18 years or older?
  • Are you scheduled for a colonoscopy (screening, check-up, or for symptoms)?
  • Do you not have inflammatory bowel disease (like Crohn's or Colitis)?
  • Are you not currently being treated for bowel cancer?
  • Do you not have a bleeding problem or take medication that could cause excessive bleeding during the procedure?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll first be asked to read and sign a consent form, making sure you understand what the study involves. When you come for your colonoscopy, you'll be randomly put into one of two groups, a bit like flipping a coin. One group will have their colonoscopy with the CADDIE AI system actively helping the doctor. The other group will have a standard colonoscopy without the CADDIE AI system assisting in real-time.

Regardless of the group you're in, your colonoscopy will proceed as normal. For any polyps the doctor finds, they will measure them and take pictures. The CADDIE device will be present during all procedures, and a video recording of your colonoscopy will be made. The study does not involve any extra tests or visits beyond your scheduled colonoscopy. There's no specific follow-up related to the study itself, as it focuses on the procedure at the time.

Potential risks and benefits

Taking part in this study means you might contribute to understanding how new AI technology could improve colonoscopy, potentially leading to earlier and more accurate polyp detection for future patients. There are no additional risks beyond those usually associated with a standard colonoscopy. Your doctor will explain these to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care, and without having to explain your decision.

Locations (1)

  • University College London Hospitals NHS Foundation Trust
    London, United Kingdom· Recruiting

Common questions

What is a polyp?

A polyp is a small growth on the lining of your bowel. Many are harmless, but some can potentially become cancerous over time.

What is the CADDIE system?

CADDIE is an Artificial Intelligence (AI) system designed to help doctors find and understand polyps more accurately during a colonoscopy.

Will CADDIE treat my polyps?

No, CADDIE does not treat polyps. It's a tool to help the doctor make a more informed diagnosis of what kind of polyp it is.

Will I know if I'm getting the CADDIE assist or not?

You will be randomly assigned to one of two groups, which means your doctor won't know which group you are in either at the time of your procedure.

Is my privacy protected?

Yes, your personal information will be protected, and the study will follow strict rules to keep your data private and secure.

How to find out more

Sharon Cheung, MSc

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Early DiAgnosis Real-Time Healthcare System for CANcer Trial…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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