A study of a test to look for possible return of oesophageal cancer after chemoradiation treatment (CYTOFLOC)

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 looking at a test called Cytosponge to see if it can be used to check for cancer of the food pipe (oesophageal cancer) after chemoradiation.

Chemoradiation is a treatment for oesophageal cancer where you have chemotherapy and radiotherapy together.

Cancer Research UK supports this study.

More about this trial

After treatment for oesophageal cancer you might have an endoscopy to check if the cancer has come back. This involves putting a tube down your throat which can be uncomfortable and can have some risks.

Cytosponge is a capsule. Inside the capsule is a sponge with a string attached. You swallow the capsule and it dissolves in your stomach releasing the sponge. The sponge is then gently pulled out using the string.

On the way out, the sponge collects cells from your oesophagus. The sponge is sent to a laboratory to see if it has collected any cancer cells.

In this study the researchers want to find out how:

many people can successfully use the Cytosponge
safe the Cytosponge is to use for people who have had chemoradiation treatment for oesophageal cancer
acceptable it is for people to use
well it works

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the trial 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 all of the following apply.

You:

have had chemoradiation treatment for your oesophageal cancer
finished your chemoradiation treatment 4 to 16 weeks ago
can swallow moist, soft, semi solid food
can swallow tablets
can have an endoscopy
are at least 16 years old

Who can’t take part

You cannot join this study if any of these apply.

You:

have enlarged veins close to the lining of the food pipe that might bleed (oesophageal varices) or a narrowing (stricture) that needs a tube (stent) to allow food and drink to pass through
are taking medication that thins the blood such as warfarin unless you are able to stop taking them for a few days (if required)
have any other medical condition, mental health condition or social condition that your doctor or the trial team think could affect you taking part in the study

Trial design

This is a feasibility study. The study team need 50 people to join.

You have the Cytosponge after chemoradiation.

If you are having a routine endoscopy, the study team aim for this to be at the same time.

If you are having surgery after chemoradiation, the study team aim for the Cytosponge to be done a few days before surgery or on the day of surgery.

You shouldn’t drink or eat for 4 hours before the Cytosponge.

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You swallow a small capsule with a drink of water. The capsule contains a sponge, covered in gelatine, which is attached to a string.

After 5 minutes, the gelatine dissolves and the sponge can be gently removed by pulling on the string. You may have a spray to numb your throat (anaesthetic Open a glossary item ) before pulling it out if needed.

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.

Questionnaire

After having the Cytosponge you fill in a questionnaire. The questions ask about:

your experience of having the Cytosponge
if you would have it again
whether you would recommend having the Cytosponge to someone else

The team would like the questionnaire to be completed straight away. But it can be taken home to complete and returned by post.

Interview

A member of the study team will arrange to have a quick talk with you a week and 2 weeks after. This could be face to face or on the phone. This is to see how you are after.

You won’t be contacted if you have surgery before this time.

Samples

The study team will ask for a piece of the sample tissue (biopsy Open a glossary item

) taken from endoscopies you might have had before or after the Cytosponge. They will also ask you to give a blood sample before you have the Cytosponge.

You don’t have to agree to either of these. You can still take part in the study.

Hospital visits

You have 2 extra hospital visits between 4 and 16 weeks after your chemoradiation. Although in some cases these 2 visits might be combined.

The 1st is to check that you can have the Cytosponge. The 2nd is to have the Cytosponge.

Side effects

Cytosponge has been used by over 2,000 people with other conditions in other clinical trials. It is very safe to use in Barrett’s oesophagus Open a glossary item and early oesophageal cancer.

The most common side effect is a mild sore throat for a day or 2 after.