Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial looking at the Cytosponge test in GP surgeries for people with heartburn symptoms (BEST3)
A small number of people who have long term symptoms of heartburn or acid reflux might develop a condition called Barrett’s oesophagus.
Having Barrett’s oesophagus slightly increases your risk of cancer of the food pipe (oesophageal cancer). This is a small increased risk. Many people with Barrett’s oesophagus do not develop cancer of the food pipe
Cancer Research UK supports this study.
More about this trial
People with Barrett's opesophagus are closely monitored. This way if cancer is found, they are diagnosed early and can start treatment as soon as possible.
Barrett’s oesophagus can be diagnosed by collecting a sample of tissue (
We know from research that the Cytosponge is safe and can be used to diagnose Barrett’s oesophagus.
For the Cytosponge test you swallow a small capsule with a sponge inside. The sponge is attached to string which you or the nurse uses to pull the sponge out. This takes a sample of the cells of the lining of the food pipe which then can be tested.
In this trial the researchers are looking at whether the Cytosponge test can be used in GP surgeries.
The main aim of this trial is to find how acceptable and how safe it is to use the Cytosponge test in GP surgeries.
Who can enter
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
You may be able to join this trial if all of the following apply. You:
- Have received a letter of invitation from your GP (you are invited to take part in this trial, you cannot volunteer)
- Have had medication prescribed by your doctor that reduces the amount of acid in your stomach (acid suppressant medication) for at least the past 6 months
- Are at least 50 years old
You cannot join this trial if any of these apply.
- You are getting regular prescriptions of medication called a non steroidal anti inflammatory drug (
- You are getting regular prescriptions of a drug called Clopidogrel
- You have had an endoscopy of the food pipe (oesophagus) in the past 5 years
- You have been diagnosed with cancer of the back of the mouth (oropharynx), cancer of the food pipe (oesophagus) or cancer where the food pipe joins the stomach (gastro oesophageal junction)
- You have been diagnosed with Barrett’s oesophagus
- You aren’t able to get to the GP surgery
- Your GP doesn’t think you should take part
Researchers want 120 GPs to take part in the trial. Half will do the Cytosponge with usual care. The other half will continue to do usual care only.
Researchers will look at the databases of the 120 GPs to find people who might be able to take part in the trial. A letter of invitation is posted to these people. They can choose:
- to allow the researchers to collect information from your medical notes – you won’t be able to be identified (anonymous) and the information will be confidential
- to have the Cytosponge test in addition, if your GP is doing it
- not to take part at all
The team need 8,988 people to join the trial.
- 4,494 people from GPs who are doing the Cytosponge with usual care
- 4,494 people from GPs who are doing usual care only
Cytosponge is a capsule about the size of a vitamin tablet. It contains a small sponge attached to string. The other end of the string is attached to a card that you or the nurse holds. You swallow the capsule with a glass of water.
After about 5 minutes the capsule dissolves in your stomach. The sponge inside is released. The nurse then gently pulls the string to remove the sponge. On the way out the sponge collects cells from the lining of your food pipe.
View a transcript of the video about the cytosponge.
The sponge might cause a bit of discomfort as it is pulled out. The nurse will remove the sponge quickly but delicately to avoid discomfort. You can also have your throat sprayed with an anaesthetic drug before pulling the sponge out. This will numb your throat.
The sponge is sent to the laboratory to look for chemical substances (
After 4 to 6 weeks your GP will have the results. They will discuss this with you and then decide if your treatment needs changing or if you should have an endoscopy.
You have an endoscopy if the Cytosponge test shows that markers are present. The endoscopy is to confirm if you have Barrett’s oesophagus or not. Your appointment for the endoscopy will be within 6 weeks of getting the results of the Cytosponge.
An endoscopy is an examination of your food pipe. A thin tube with a camera on the end goes down your throat so the doctor can have a look at the lining of your food pipe. They will take small samples of tissue (biopsies) for some tests.
A year after joining the study the team might invite you to have an endoscopy if you haven’t had one. This also includes people who had usual care only. They will use the results of the endoscopies to find out how often a diagnosis of Barrett’s oesophagus might be missed.
When you agree to join the study you fill in a questionnaire about your general health, lifestyle and heartburn or reflux symptoms.
About 2 weeks later the team will post you another questionnaire. The questions ask about your experience of having the Cytosponge test done. A stamped addressed envelope is provided for you to post the questionnaire back.
Before you have the Cytosponge test the nurse:
- will ask for a spit (saliva) sample
- will take your height, weight and hip measurement
A week to 2 weeks afterwards a member of the team will phone you to see how you are.
Over 3,000 people have had the Cytosponge test done and there have been no serious side effects reported.
You might have a mild sore throat for about a day afterwards.
There is a very small risk you might have some bleeding. Your GP or clinic nurse will assess you if this happens. You also have a card of instructions to follow if this happens at home.
There is a very small risk that the sponge might become detached from the string. Or that it will be difficult to remove the sponge. Your GP will assess you and arrange an endoscopy at the local hospital where the sponge can be safely removed.
How to join a clinical trial
Professor Rebecca Fitzgerald
Cambridge University Hospitals NHS Foundation Trust
Cancer Research UK
MRC Cancer Unit - University of Cambridge
Queen Mary University of London