A study to see how well a new way of screening for Barrett's oesophagus works (BEST2)

Cancer type:

Oesophageal cancer

Status:

Open

Phase:

Other

This study is looking at a new screening tool called cytosponge for a condition called Barrett’s oesophagus. This trial is supported by Cancer Research UK.

More about this trial

In Barrett’s oesophagus, there are changes in the normal cells that line the food pipe (oesophagus or gullet). This is caused by acid coming back up the food pipe from the stomach (acid reflux), which can cause symptoms such as indigestion and heartburn.

Over a long period of time, people with Barrett's oesophagus may develop ulcers or a narrowing of the oesophagus. It is also recognised as a risk factor for oesophageal cancer. People with Barrett’s oesophagus usually have tests every year or 2 to check for these conditions.

Barrett’s oesophagus can be diagnosed by having a biopsy during a test called an endoscopy. But endoscopy can be uncomfortable and does have some risks. It is not practical for everyone who has heartburn or indigestion to have an endoscopy. So, many cases of Barrett’s oesophagus are not picked up.

Doctors are trying to find a simple way of screening people who are at high risk of getting Barrett’s oesophagus. If they can detect Barrett’s oesophagus in more people, they may be able to develop ways of stopping the disease becoming oesophageal cancer.

In this study, the researchers are trying to find out if something called a cytosponge can pick up Barrett’s oesophagus. They will also look for markers that may show which people are at a higher risk of Barrett’s oesophagus becoming cancer. In the future this could help them to work out who needs more careful monitoring or treatment, but will not affect any further screening or treatment for people taking part in this trial.

Who can enter

You can enter this trial if any of the following apply. You:

  • Have Barrett’s oesophagus, or you have heart burn and indigestion and are considered to be at high risk of Barrett’s oesophagus
  • Have had abnormal areas in the lining of the oesophagus (food pipe) removed and are due to have a repeat endoscopy for Barrett’s
  • Have had radiofrequency ablation (RFA) Open a glossary item for abnormal cells and you are due for a repeat endoscopy for Barrett’s oesophagus as long as there hasn’t been a narrowing of the oesophagus (stricture)

As well as the above the following must also apply.
You:

  • are due to have an endoscopy
  • are at least 18 years old

You cannot enter this trial if you

  • Have a tumour in your oesophagus, in the area of your throat at the back of your mouth (the oropharynx), or at the point where your oesophagus meets your stomach (the gastro oesophageal junction)
  • Have had previous treatments to destroy abnormal cells, such as light therapy (photodynamic therapy) for Barrett’s oesophagus
  • Have difficulty swallowing
  • Have a narrowing of your oesophagus (stricture) or swollen veins near to the lining of the oesophagus (varices)
  • Are taking drugs to thin your blood (anticoagulants)
  • Have had a heart attack or another heart problem that needed treatment in the last 6 months
  • Have had a stroke in the last 6 months that affected your swallowing
  • Don’t eat beef (this is because you must swallow a capsule that is coated in gelatine which is made from beef)

Trial design

This study aims to recruit up to 1,400 people. Some of the people taking part are known to have Barrett’s oesophagus, some have a high risk of developing it. And some might have already had radiofrequency ablation for Barrett’s oesophagus.

You have the cytosponge test and the endoscopy as well. This means the researchers can compare the findings of the cytosponge test with the results of the endoscopy to see how accurate the cytosponge is.

If you agree to take part, you will have the test on the same day as you have your endoscopy. A research nurse will ask you some questions about your general health and lifestyle as well as measuring your height and weight. Then they will ask you to swallow a small capsule called a cytosponge, along with a drink of water. The capsule contains a sponge that is attached to a string.

The sponge is covered in gelatine which takes about 5 minutes to dissolve in your stomach. The sponge is then gently removed by pulling the string. You may have a spray to numb your throat. As the sponge is pulled up and out of your mouth, it collects cells from the lining of your oesophagus, which can then be studied in the laboratory.

Barrett's Oesophagus Screening Research | Cancer Research

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View a transcript of the video about the cytosponge.

After having the cytosponge test, you have your endoscopy as planned. Depending on the results, you may have more endoscopies in the future. The research team may ask you to have the cytosponge test again. But you do not have to agree to this if you don’t want to.

Focus groups and interviews
The study team might ask you to take part in small focus groups of about 6 to 10 people. This involves 3 separate sessions at the Cambridge Biomedical Campus. The team ask you about taking having the cytosponge tests and what you thought about it.  Each session takes about an hour to an hour and a half. The conversation is audio recorded. 

They might also ask you to take part in an interview with a member of the research team. The interview takes about an hour and is audio recorded. 

You don’t have to agree to the focus group or interview if you don’t want to. It won’t affect you taking part in the main study.

Hospital visits

You have the cytosponge test on the same day as your endoscopy, so there are no extra hospital visits.

Side effects

Having the cytosponge test is not painful and people who took part in an earlier study didn’t have any other serious side effects. You may have a mild sore throat for about 24 hours. But this is also a common side effect of having an endoscopy, so you are unlikely to notice any difference if you have the cytosponge test. Your doctor will talk to you about the possible risks of having an endoscopy before you agree to have the test.

Location

Cambridge
Nottingham

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Rebecca Fitzgerald

Supported by

Cambridge University Hospitals NHS Foundation Trust
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Medical Research Council (MRC)
NIHR Clinical Research Network: Cancer
University of Cambridge

Other information

This is Cancer Research UK trial number CRUK/10/041.

We have more information about the work of Dr Rebecca Fitzgerald.

Freephone 0808 800 4040

Last review date

CRUK internal database number:

4161

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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