A study looking at the capsule sponge test to find a condition called gastric intestinal metaplasia (CyGIM study)
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This study is looking to see how well the capsule sponge test works to find a stomach condition. This condition is called gastric intestinal metaplasia or GIM for short.
This is study is for people who have GIM and are due to have an endoscopy to monitor this condition. The researchers are also looking for some people who haven’t been diagnosed with GIM. This is the control group.
The study is for people being cared for at the Cambridge University NHS Foundation Trust.
More about this trial
The capsule sponge test is used to screen for a condition of the food pipe (oesophagus). This condition is called 
. It means that some cells in the lining of the food pipe have started to change. In a small number of people, these cells may develop into oesophageal cancer over a long period of time.
The capsule sponge test is a quick and simple test. It collects cells from along the lining of the stomach and food pipe. Specialists can then look at the cell samples for signs of cell changes (dysplasia).
Researchers now want to see if they can use this test to detect a condition called gastric intestinal metaplasia (GIM). This condition means the normal lining of the stomach changes to look like the lining of the . It increases the risk of developing stomach cancer. Not everyone who has GIM will go on to develop stomach cancer.
You usually have an to investigate stomach problems if your doctor thinks it is necessary. Doctors want to see if the capsule sponge test can diagnose GIM instead of having an endoscopy. Having an endoscopy can be uncomfortable, inconvenient and it does have some risks.
In this study, some people have a diagnosis of GIM. And some people have stomach symptoms, but don’t have GIM. Everyone taking part will have a capsule sponge test before they have an endoscopy.
People who don’t have a diagnosis of GIM are the control group in this study. It’s useful to have a control group so the results of those with GIM can be compared to those without GIM.
The main aims of the study are to find out:
- if the capsule sponge test works well enough to pick up gastric intestinal metaplasia (GIM)
- whether there are new
biomarkers that may show who is at a higher risk of GIM becoming cancer
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
For people who have gastric intestinal metaplasia (GIM)
You may be able to join this study if all of the following apply. You:
- have had an endoscopy in the past and tissue samples (
biopsies ) showed that you have GIM of the upper part of your stomach - are well enough to have an
endoscopy - are at least 18 years old
For people who don’t have GIM
You may be able to join this study if all of the following apply. You:
- have symptoms of stomach or food pipe problems (upper gastro intestinal symptoms)
- have been referred for an endoscopy
- are well enough to have an endoscopy
- are at least 18 years old
Who can’t take part
You cannot join this study if any of these apply. You:
- have cancer of the mouth, oesophageal cancer or cancer where your food pipe joins your stomach (gastro oesophageal junction cancer). Please note, this only applies if you have cancer that is stage T2 or above. Your doctor will know this.
- have problems swallowing
- have been diagnosed with
Barrett’s oesophagus in the past - have swollen veins near to the lining of the oesophagus or a narrowing of the oesophagus that needs widening (dilation)
- can’t stop taking medication to thin the blood if you have this. This would need to be done in a timely way to prepare for the procedure. Your doctor will talk to you about this if it applies.
- have had a heart attack or a significant
heart problem within 6 months of having the capsule sponge test - have had a
stroke that affected your swallowing within 6 months of having the sponge test - have had
photodynamic therapy , radiofrequency ablation or heat treatment (argon plasma coagulation) to treat Barrett oesophagus that had cell changes
Trial design
The trial is only for people who attend the Cambridge University NHS Foundation Trust.
The study team need 50 people to take part in total for the first part of the trial.
This is:
- 25 people who have gastric intestinal metaplasia (GIM)
- 25 people who don’t have GIM (the control group)
The trial team hope to recruit more people to join a second part of the trial. This part will only go ahead if the first part shows promising results. We will add more information about this when it becomes available.
Gastric intestinal metaplasia group
A team of doctors will identify people who have GIM to take part. This group are having an endoscopy as part of their standard of care. This is to monitor this condition.
Your doctor will check if you are suitable for the study. They will approach you and ask if you might be interested in joining. You’ll have a chance to ask any questions you may have.
Control group
This group is for people who haven’t been diagnosed with GIM. But they have been referred to have an endoscopy for a stomach or food pipe problem.
You will get a letter inviting you to take part. The team will contact you a few weeks or days before your endoscopy to see if you are interested in joining the study.
When you go to hospital to have your endoscopy, a research nurse will talk to you about the study. You’ll have a chance to ask any questions you may have.
Both groups
If you agree to take part, a member of the research team will ask you some questions about your health and lifestyle. They will also:
- weigh you
- measure your height
- measure your waist and hips
You then have the capsule sponge test followed by your routine endoscopy. This means the researchers can compare the findings of the capsule sponge test with the results of the endoscopy. This helps them to see how accurate the capsule sponge test is.
The capsule sponge test is approved and thousands of people have had the test so far. The capsule sponge is a small sponge inside a capsule. The capsule is suitable for vegetarians. It is similar in size to a vitamin pill and is attached to a thread. You swallow the capsule along with the string with a glass of water. Once swallowed, the capsule dissolves in the stomach after about 7 minutes. This releases the sponge.
A trained nurse then gently removes the sponge by pulling the thread. This takes a few seconds. As it is pulled out, the sponge collects cells from the lining of the stomach and food pipe.
The test takes around 10 minutes in total. You can choose whether you want to have an anaesthetic throat spray before they withdraw the sponge.
You can watch a short video about having the sponge test.
View a transcript of the video about the sponge test.
After having the capsule sponge test, you have your endoscopy as planned. The team will take 8 tissue samples from the stomach and a small sample of fluid. This will help researchers to compare the results of the sponge test with those of the endoscopy.
Samples for research
After the capsule sponge test, you will have a sample of blood taken for research.
Some of the samples taken from the stomach will also be used for research. They will be analysed in the laboratory. This is to help to find extra tests to help to improve the sponge test.
Hospital visits
You won’t have any extra hospital visits or follow up appointments if you take part in this study. You have your endoscopy at the hospital as planned.
Side effects
Thousands of people have had the capsule sponge test with no serious side effects.
The sponge test isn’t painful and most people find the capsule easy to swallow. You might have a mild sore throat after the test.
There is a very small risk of bleeding at the back of the throat. The nurse will look out for this and treat it straight away.
There is also a very small risk that the sponge could come off the thread in your stomach or the nurse is unable to remove it. This means you would need an endoscopy to remove it. This won’t be too much trouble for you as you are having your planned endoscopy straight after the sponge test.
A member of the team will talk to you about all the possible side effects before you agree to have the test.
We have more information about having an endoscopy.
Location
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.
Chief Investigator
Dr Massimiliano di Pietro
Supported by
University of Cambridge
Cambridge University Hospitals NHS Foundation Trust
Medical Research Council (MRC)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
