Not yet recruitingNAINTERVENTIONAL

A Study of Barrett's Esophagus Patients: Optimization of a Risk Model to Better Predict the Development of Cancer Recurrence and the Effect of Risk Profile Disclosure on Patient Quality of Life and Fear of Cancer

This study aims to improve how we predict if cancer might come back in people with Barrett's Oesophagus. We'll collect samples like blood and small tissue pieces during routine endoscopies. We'll also use new genetic tests to build a better risk model. A key part of the study is understanding how knowing your personal cancer risk affects your quality of life and worries about the future. Participants will be divided into two groups: one will be told their risk profile, and the other won't. Everyone in the study will have more regular check-ups than usual. This research hopes to lead to better, more personalised care for people with Barrett's Oesophagus.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University Hospital, Antwerp

Enrolment target

266

Start

01 Jun 2026

Estimated completion

31 Dec 2030

Barrett Esophagus Barrett Esophagus Adenocarcinoma Adenocarcinoma - GEJ Gastroenterology Gastroenterological Cancer

What is this study about?

This research study is for people who have a condition called Barrett's Oesophagus and are suspected of having very early oesophageal cancer. Barrett's Oesophagus means the lining of your gullet (oesophagus) has changed, and it can sometimes, but not often, lead to cancer. The main goal of this study is to find better ways to predict if early oesophageal cancer might come back after treatment. We want to understand what makes some people more likely to have a recurrence than others. We're doing this by looking closely at samples from your body, using advanced genetic tests.

We're also very interested in how people feel when they have Barrett's Oesophagus and are at risk of cancer. A big part of this study is understanding how knowing your personal risk of cancer coming back affects your daily life and your worries. We want to see if being told about your risk profile helps or hinders your well-being. This information will help doctors communicate better with patients in the future.

Ultimately, by combining genetic information with how patients feel, we hope to develop a more accurate way to understand individual risk. This could lead to more personalised care, where doctors can tailor follow-up and monitoring plans to each person's specific needs, potentially leading to earlier detection and better outcomes.

Key takeaways

Aims to predict cancer recurrence in Barrett's Oesophagus more accurately.
Investigates how knowing your cancer risk affects your well-being.
Involves extra samples (blood, tissue, brushings) during routine endoscopies.
You'll complete questionnaires on quality of life and worry.
You might be informed of a genetic risk profile, or not (randomised).
Study findings will help improve future patient care.

Who may be eligible?

To join this study, you need to be at least 18 years old and have Barrett's Oesophagus. You must also be coming to one of the hospitals taking part because your doctors suspect you might have very early oesophageal cancer that they want to treat.

It's very important that you fully understand what the study involves before you agree to take part. You'll need to be able to give your clear permission to participate.

This study might not be suitable if you currently have another type of cancer in your digestive system, or if you have severe health problems that would make an endoscopy (a camera test) under sedation unsafe. Also, if you have certain blood clotting issues, or if you've recently had or are planning to have chemotherapy/radiotherapy, you might not be able to join. Your doctors will check all these details to make sure the study is right for you.

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 years old or older?
Do you have a diagnosis of Barrett's Oesophagus?
Are you having an endoscopy because your doctor suspects very early oesophageal cancer?
Are you able to understand the study information and give your permission?
Do you not have another active cancer in your digestive system?
Are you generally well enough for an endoscopy with sedation?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll have an initial meeting where we'll confirm you're eligible and gather some basic information. You'll then have two routine gastroscopy appointments, which are camera tests of your gullet. During these procedures, we'll take some extra samples compared to a standard endoscopy: a blood sample, cells brushed from your gullet, and small pieces of tissue from your gullet and stomach. Taking these extra samples will make the endoscopy about 10-15 minutes longer than usual.

At several points during the study, you'll be asked to complete short questionnaires on your phone to assess your quality of life and any worries you have about cancer. The study is randomised, meaning a computer will put you into one of two groups: one group will be told their personal risk profile based on genetic tests, and the other won't. Everyone in the study will have slightly more frequent check-ups than standard care, which will help us follow your progress over up to 5 years. You'll be contacted a total of four times for appointments: a screening visit, two sample collection visits, and one visit to discuss your risk profile if you are in that group. The follow-up for the study will happen during your routine appointments, so you won't need extra visits for that.

Potential risks and benefits

Participating in this study means some extra time during your endoscopy procedure to collect samples. While endoscopies are generally safe, there are small risks, like discomfort or, very rarely, damage to the gullet. The blood draws are routine and carry minimal risk. A potential benefit is that your follow-up schedule will be more intensive than standard care, which might lead to earlier detection of any issues. For those who receive their risk profile, it could provide valuable personal information, though knowing this might also cause some worry. Whether or not you are told your risk, the information gathered from your samples will help researchers understand Barrett's Oesophagus better, potentially leading to improved care for future patients. Remember, taking part is completely your choice, and you are free to withdraw from the study at any time without affecting your medical care.

Locations (10)

Antwerp University Hospital
Verified postcode
Edegem, Belgium
Sint-Augustinus Hospital (ZAS)
Verified postcode
Wilrijk, Belgium
Ghent University Hospital (UZ Gent)
Verified postcode
Ghent, Belgium
AZ Delta
Verified postcode
Roeselare, Belgium
Rigshospitalet
Verified postcode
Copenhagen, Denmark
CHU LILLE - Centre Hospitalier Universitaire de Lille
Verified postcode
Lille, France
University Hospital Leipzig
Verified postcode
Leipzig, Germany
St James's Hospital
Verified postcode
Dublin, Ireland
IRCCS Ospedale San Raffaele
Verified postcode
Milan, Italy
Karolinska University Hospital
Verified postcode
Solna, Sweden

Common questions

What is Barrett's Oesophagus?

It's a condition where the lining of your gullet (food pipe) has changed. It's often caused by long-term acid reflux and can sometimes lead to cancer, though this is rare.

Will I get personalised medical advice from this study?

This study is for research, not to give individual medical advice. Your doctors will continue to manage your care as usual. If you're in the group that receives a risk profile, this information is for study purposes.

What happens if I change my mind about taking part?

You are free to leave the study at any time without having to give a reason. Your decision won't affect your medical care in any way.

Will I have to pay to be in the study?

No, you will not have to pay to participate in this study. All study-related procedures will be covered.

How long will the study last for me?

The active part of collecting samples and questionnaires will happen over a relatively short period, but we will monitor your progress during your routine follow-up appointments for up to 5 years.

How to find out more

Martin Wyckmans, Resident Physician

martin.wyckmans@uza.be +323 821 32 80 Official trial record

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