RecruitingOBSERVATIONAL

AI-enabled Endoscopic Prediction of Post-operative Recurrence in Crohn's Disease

This study aims to discover how to better predict if Crohn's disease will return after surgery. While surgery can help, the disease often comes back, and current tests aren't always great at predicting this early. Researchers are using special imaging during a colonoscopy, along with artificial intelligence (AI), to look closely at the gut after surgery. They also collect samples like blood and stool. By combining all this information, they hope to identify patients who are at a higher risk of their Crohn's returning. This could help doctors give early treatments to stop the disease from progressing.

At a glance

Status

Recruiting

Sponsor

University College Cork

Enrolment target

225

Start

01 May 2024

Estimated completion

31 May 2026

Crohn Disease

What is this study about?

Many people with Crohn's disease need surgery at some point. While surgery can relieve symptoms, it's not a permanent cure, and the disease often comes back for many patients. When Crohn's returns after surgery, it's called post-operative recurrence. Doctors want to find better ways to predict who might experience this recurrence early on, so they can offer treatments sooner.

This study is looking at new and advanced ways to examine the gut after surgery. They're using special imaging techniques during a colonoscopy that can show very small changes in the lining of the intestine. Think of it like a super-magnifying glass for your gut. They're also using artificial intelligence (AI) to help analyze these images, which can spot patterns a human eye might miss. Alongside this, they'll collect information from blood, stool, and saliva samples, and your overall health information.

The main goal is to combine all these different pieces of information – the detailed images, lab results, and your health data – to create a clearer picture of whether someone is likely to have their Crohn's disease return. By understanding who is at higher risk, doctors could potentially start treatments earlier, which might help prevent the disease from getting worse or needing more surgery down the line. It's about finding a more precise way to care for people with Crohn's.

Key takeaways

Researchers are seeking better ways to predict Crohn's recurrence after surgery.
The study uses advanced colonoscopy imaging and artificial intelligence (AI).
It also collects blood, stool, and saliva samples.
The aim is to identify high-risk patients for earlier prevention.
This is a non-interventional, observational study, meaning no new treatments are given.
It could lead to more personalised care for Crohn's patients in the future.

Who may be eligible?

This study is looking for adults aged between 18 and 75 who have a confirmed diagnosis of Crohn's disease. You would need to have been diagnosed at least six months before joining the study.

Crucially, you must have either had surgery for your Crohn's disease within the last three months, or be planning to have surgery soon. This study is specifically focused on understanding what happens after surgery.

There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, have serious health problems that would make it risky, or if you have an ostomy. Also, if you have certain allergies (like to nuts or shellfish) or take specific medications (like beta-blockers), you might not be able to have one of the special imaging tests, but you might still be able to join the main study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 75 years old?
Do you have a confirmed diagnosis of Crohn's disease?
Have you had Crohn's disease for at least six months?
Have you had Crohn's surgery within the last 3 months, or are you planning one?
Are you pregnant or breastfeeding?
Do you have a serious medical condition that might prevent you from having a colonoscopy?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have a colonoscopy, which is a common procedure where a thin, flexible tube with a camera is used to look inside your bowel. During this, the researchers will use some advanced imaging techniques and might take small tissue samples (biopsies). You'll also have an intestinal ultrasound, which is a scan to look at your bowel, and provide samples of your blood, stool (poo), and saliva (spit). Your health will be followed over time, which might involve future visits or check-ups. The study does not specify how many visits or the total duration, but it involves several tests and ongoing observation.

Potential risks and benefits

Participating in this study might offer the benefit of a more thorough assessment of your Crohn's disease after surgery, potentially helping researchers find better ways to manage the disease in the future. However, there are potential risks, including those normally associated with colonoscopy, such as discomfort or a small risk of bleeding or perforation. Some advanced tests also have their own specific risks, like allergic reactions to dyes used in certain scans. You are free to withdraw from the study at any time without affecting your medical care.

Locations (15)

University of Leuven
Verified postcode
Leuven, Belgium· Active not recruiting
University of Calgary
Verified postcode
Calgary, Canada· Recruiting
University Hospital Erlangen
Verified postcode
Erlangen, Germany· Active not recruiting
Cork University Hospital
Verified postcode
Cork, Ireland· Active not recruiting
Mercy University Hospital
Verified postcode
Cork, Ireland· Active not recruiting
University College Dublin
Verified postcode
Dublin, Ireland· Recruiting
University College Hospitals Galway
Verified postcode
Galway, Ireland· Active not recruiting
Rabin Medical Centre
Verified postcode
Tel Aviv, Israel· Recruiting
Istituto Clinico Humanitas
Verified postcode
Rozzano, Italy· Active not recruiting
ASST Spedali Civili
Verified postcode
Brescia, Italy· Active not recruiting
ASST Fatebenefratelli Sacco
Verified postcode
Milan, Italy· Recruiting
IRCCS Cà Granda Ospedale Maggiore
Verified postcode
Milan, Italy· Recruiting

Common questions

What is the main goal of this study?

The main goal is to find better ways to predict if Crohn's disease will return after surgery, using new imaging techniques and AI.

What is a colonoscopy, and why is it part of the study?

A colonoscopy is a procedure to look inside your large bowel. In this study, it's used with special cameras to see very detailed changes in the gut after surgery.

What is AI and how is it used?

AI (Artificial Intelligence) is used to help analyze the detailed images taken during the colonoscopy, helping researchers spot patterns that might predict disease recurrence.

Do I need to have recently had surgery to join?

Yes, you need to have either undergone surgery for Crohn's within the last three months or have surgery planned soon.

Will this study help my Crohn's immediately?

This is a research study to understand the disease better in the long term. While it might give you a detailed check-up, it's not designed to provide immediate individual treatment recommendations.

How to find out more

Michelle O'Riordan

moriordan@ucc.ie +353 (0)21 4901759 Official trial record

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