A study using Cytosponge to find Barrett’s oesophagus and early oesophageal cancer (DELTA)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Oesophageal cancer

Status:

Closed

Phase:

Other

This study is using the Cytosponge test to identify who might have a higher risk of developing Barrett’s oesophagus and oesophageal cancer.

It is open to people who:

are getting repeat prescriptions for heartburn and indigestion medicine
have ongoing heartburn and indigestion and are going to have an endoscopy
have been previously diagnosed with Barrett’s oesophagus and are on a surveillance programme

More about this trial

Barrett’s oesophagus is a condition where cells on the lining of your food pipe (oesophagus Open a glossary item ) have changed.

Acid in your stomach can irritate the lining of the oesophagus causing indigestion Open a glossary item . A symptom of indigestion is heartburn. The treatment for ongoing indigestion is medication. Some people who have regular heartburn develop a condition called Barrett’s oesophagus.

You have a slightly higher chance of developing oesophageal cancer if you have Barrett’s oesophagus but the risk is still small. Many people with Barrett’s oesophagus don’t develop cancer.

Your doctor might refer you to the hospital for an endoscopy if you have ongoing indigestion. During the endoscopy you might have cells from the lining of the oesophagus taken. This is to see if you have Barrett’s oesophagus or early oesophageal cancer. But an endoscopy can be uncomfortable and does have some risks.

Cytosponge is a simple and safe test. It collects cells from the oesophagus without having an endoscopy.

You swallow a capsule with a sponge inside. Attached to the sponge is a piece of string. After a few minutes the nurse pulls out the sponge using the string. This collects cells from the lining of the oesophagus. The nurse sends the sponge to the lab to see if there are any abnormal cells.

In this study the team are looking for people who are either:

getting repeat prescriptions from their GP for ongoing heartburn or indigestion, or
going to the hospital for an endoscopy because they might have Barrett’s oesophagus

The aims of this study are to find out:

how practical and possible it is to use the Cytosponge to identify Barrett’s oesophagus and monitor those who have already been diagnosed
what people think about the test
what barriers there are to using the Cytosponge and what helps

Who can enter

The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this study if one of the following apply.

You have repeat prescriptions from your GP for heartburn or indigestion medicines.
You are seeing your GP because you have long term symptoms of heartburn or indigestion.
Your GP has referred you to hospital to have a test to look at problems with your food pipe (oesophagus).
You are having a routine check up appointment for Barrett’s oesophagus.

If you are seeing your GP for a repeat prescription or for long term symptoms of heartburn or indigestion you must be at least 40 years old to join the study.

Who can’t take part

You cannot join this study if you are seeing your GP or your GP has referred you to have a test and any of the following apply. You:

have a regular prescription of non steroidal anti inflammatory drugs (NSAIDs )
have or had a cancer of the mouth and upper part of the throat (oropharynx ), a cancer of the food pipe (oesophagus ), a cancer where the food pipe joins the stomach (gastro oesophageal ) or you have Barrett’s oesophagus
have had surgery to the food pipe
have difficulty swallowing due to a stroke or a problem with how your brain or your spinal cord works
have enlarged swollen veins in your food pipe
have cirrhosis of the liver
are taking medication such as warfarin for blood clots and you can’t stop taking them for a short time
have another medical condition or mental health problem that your doctor or the study team thinks could affect you taking part

Trial design

The study team need between 1,000 and 3,000 people to join the study. That is:

500 to 1,500 people who are seeing their GP
500 to 1,500 people who are having tests for heartburn or indigestion symptoms

You have a Cytosponge test. You have it either at a mobile unit or at the hospital.

You see a nurse who asks you a few questions about your general health.

You can’t eat or drink for 4 hours before having the Cytosponge test. You can take a sip of water if there are daily medications you need to take.

For the test you swallow a capsule with a glass of water. The capsule contains a sponge with a string attached. When the capsule dissolves the sponge is gently pulled out using the string. The sponge collects samples of tissue from your food pipe as it is pulled out. The whole procedure takes about 10 minutes.

Barrett's Oesophagus Screening Research | Cancer Research

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The sponge is sent to the lab. Specialists (pathologists Open a glossary item ) in the laboratory look at the cells in the sponge to see if there are signs of Barrett’s oesophagus.

You might need to have the procedure again if there are not enough cells in the sponge for the laboratory to test for Barrett’s.

A member of the study team will watch the test if you agree. They ask if you want to take part in an interview or a focus group. This is to find out what you thought about the test. You don’t have to agree to this. You can still take part in the study.

You fill in a questionnaire. The questions ask about:

your general health
your lifestyle
whether you have heartburn, indigestion or any other symptoms
your experience of having the Cytosponge test

Hospital visits

Your doctor might refer you to the hospital to have an endoscopy or a CT scan. They will talk to you about this before they refer you.

Side effects

Cytosponge is a safe procedure. You can carry on with your normal activities after having the test.

Swallowing the capsule is not painful and most people don’t have any problems doing so.

You might have a slightly sore throat for a few days after. You can take throat lozenges or paracetamol to soothe it.

There is a very small risk that the sponge could detach from the string. Or that the nurse is unable to pull the sponge out. This happens in less than 1 out of 2,000 times. If this happens you have an endoscope to remove the sponge.

There is also a very small risk of bleeding.