RecruitingOBSERVATIONAL

AI-driven Narrow-band Imaging Score for Disease Assessment and Outcome Prediction in Ulcerative Colitis

Doctors are working to find a better way to assess Ulcerative Colitis (UC). This study is developing a new, easy-to-understand scoring system using advanced colonoscopy techniques. These techniques help doctors get a very close look at the lining of the bowel, especially at the tiny blood vessels, to see if the UC is calm or mildly inflamed. The new scoring system will then be compared to current methods to see how well it works and if it can predict long-term changes in UC. The study also aims to use artificial intelligence (AI) to make these checks even more consistent and reliable, ultimately helping personalise care for people with UC.

At a glance

Status

Recruiting

Sponsor

University College Cork

Enrolment target

300

Start

04 Nov 2024

Estimated completion

30 Sep 2027

Ulcerative Colitis (UC)

What is this study about?

If you have Ulcerative Colitis (UC), you'll know that doctors often use a colonoscopy to check on your condition. This study is all about making those checks even better. Currently, doctors look at the lining of your bowel to see how inflamed it is. This study is developing a new, simpler way to score the inflammation using special features of the colonoscopy camera, like Narrow-Band Imaging (NBI), which highlights tiny blood vessels.

The main goal is to create a score that can clearly tell the difference between UC that is very quiet and UC that has just a little bit of inflammation. This is important because even mild inflammation can sometimes lead to problems later on. The new score will then be tested to see if it's more accurate than current methods and if it can help predict how your UC might change over the years. This could mean doctors get a clearer picture of your condition and can tailor treatments more effectively.

Another exciting part of this study is its use of artificial intelligence (AI). The researchers are looking at how AI can help standardise the way doctors assess your bowel during a colonoscopy. By using AI to analyse the images, they hope to make the assessment more consistent, no matter which doctor is performing the colonoscopy. This could lead to more precise diagnoses and better predictions about the course of your UC, ultimately improving your care.

Key takeaways

Aims to create a new, simpler way to assess Ulcerative Colitis.
Uses advanced colonoscopy techniques to look closely at bowel inflammation.
Explores using AI to make UC assessments more consistent and accurate.
May help predict how Ulcerative Colitis could progress over time.
Focuses on improving future care for people with UC.

Who may be eligible?

To take part in this study, you need to be an adult between 18 and 75 years old and have had a definite diagnosis of Ulcerative Colitis for at least six months. You would also need to be having a colonoscopy for your routine check-up, either to see how active your disease is or as part of a cancer screening plan.

However, there are certain situations where you wouldn't be able to join. For example, if you have any medical reasons that make a colonoscopy or taking small tissue samples (biopsies) unsafe for you. This includes conditions like severe bleeding problems. Also, if you have a very severe gut swelling called toxic megacolon, or if your bowel hasn't been properly cleaned out before the colonoscopy, you wouldn't be able to participate.

Other reasons for not being able to join include if you have other serious health problems that shorten your life expectancy or make a colonoscopy too risky, or if you are pregnant or breastfeeding. You must also be able to understand and agree to take part, and if you've been in another experimental trial recently, it must have finished at least 30 days before this study starts.

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 18 to 75 years old?
Do you have a diagnosis of Ulcerative Colitis that has lasted at least 6 months?
Are you due to have a colonoscopy for a routine check-up?
Are you generally in good health with no serious medical conditions that would make a colonoscopy risky?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join this study, you might have extra steps during your routine colonoscopy. This might involve using special camera settings (like Narrow-Band Imaging) to get detailed views of your bowel. Small tissue samples (biopsies) will also be taken during the colonoscopy, as is common for UC. You may also be asked to provide blood and stool samples. During the study, you'll have clinical follow-up appointments, which means doctors will continue to monitor your health and UC over time. The study doesn't specify a total duration, but it involves several phases of development and validation of the new scoring system.

Potential risks and benefits

Taking part in this study may offer the benefit of contributing to new knowledge that could improve how Ulcerative Colitis is diagnosed and managed in the future, potentially leading to more accurate assessments and personalised treatment for patients. The main procedures, like colonoscopy and biopsies, carry standard risks that your doctor will discuss, such as discomfort, a small risk of bleeding, or, very rarely, a tear in the bowel. Providing blood and stool samples are generally low-risk. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (11)

University of Leuven
Verified postcode
Leuven, Belgium· Not yet recruiting
Klinikum Luneburg
Verified postcode
Lüneburg, Germany· Not yet recruiting
University College Cork
Verified postcode
Cork, Ireland· Recruiting
Ospedale S. Maria del Prato
Verified postcode
Feltre, Italy· Not yet recruiting
University of Bari
Verified postcode
Bari, Italy· Not yet recruiting
Istituto Clinico Humanitas
Verified postcode
Milan, Italy· Not yet recruiting
University Vita-Salute San Raffaele
Verified postcode
Milan, Italy· Not yet recruiting
University of Naples
Verified postcode
Naples, Italy· Recruiting
University of Pavia
Verified postcode
Pavia, Italy· Not yet recruiting
Showa University
Verified postcode
Tokyo, Japan· Not yet recruiting
Changi General Hospital
Verified postcode
Singapore, Singapore· Not yet recruiting

Common questions

What is 'Narrow-band Imaging'?

It's a special colonoscopy technique that uses filters to show the tiny blood vessels in your bowel lining more clearly, helping doctors spot changes related to Ulcerative Colitis.

What does 'Artificial Intelligence (AI)' do in this study?

AI will help analyse the images from your colonoscopy to make the assessment of your Ulcerative Colitis more consistent and potentially help predict how your condition might develop.

Will this study change my current treatment?

This study aims to develop new assessment tools; it's not designed to change your current treatment, but to potentially improve future care based on more accurate information.

How long will I be involved in the study?

The study description doesn't specify a fixed duration, but it involves your participation during a routine colonoscopy and future clinical follow-up to track your health.

Are there any extra tests besides my usual colonoscopy?

Yes, you might be asked for blood and stool samples, and the colonoscopy itself might involve using special camera settings to capture more detailed images.

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.