A study looking at cell changes in pre cancer and cancer where the food pipe meets the stomach (OCCAMS)
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This study is both using the latest technology to learn more about how cancer develops, and testing a new system to work out cancer stage for people with cancer where the food pipe meets the stomach (gastro oesophageal cancer). This study is supported by Cancer Research UK.
More about this trial
In this study, researchers will look at changes in cells from people with a pre cancer or cancer of the gastro oesophageal junction. They hope to be able to learn more about the causes of cancer to help them choose new treatments in future.
The study team have also developed a new way of working out how advanced gastroesophageal cancer is (the cancer stage). They think this will give doctors more information about the likely outcome of the cancer (the prognosis) than the system used at the moment. It combines a new way of looking at how the cancer spreads using scans, alongside looking at changes in the DNA of cancer cells.
The aims of this study are to learn more about how cancer develops, and to test this new staging system on people starting treatment.
Everyone taking part in this study will give blood and tissue samples when they are giving samples as part of their routine care. You will not have any direct benefit from taking part in this study, and it is unlikely to change your treatment plan in any way. But the results will be used to help people with cancer in the future.
Who can enter
You may be able to enter this study if you are being cared for at one of the hospitals taking part and are in one of the following situations
- You have cells in your food pipe that are growing very abnormally (high grade Barrett’s oesophagus)
- You have had Barrett’s oesophagus and you now have a very early cancer called early intramucosal carcinoma
- You have a type of cancer called an adenocarcinoma, in your stomach, food pipe (oesophagus) or where your food pipe and stomach meet (the gastro oesophageal junction)
And you may have treatment that uses endoscopy or surgery such as
- Using a very thin wire to remove abnormal or cancerous tissue (endoscopic mucosal resection) with or without radiowave treatment called radiofrequency ablation
- Putting in a tube (stent) to allow food and drink to pass through
- Surgery to remove all or part of your food pipe, or your stomach and the lower part of your food pipe
Trial design
This study aims to recruit around 4,000 people.
Everyone taking part will give extra samples of blood or tissue for research. The study team will take these when you are already giving samples as part of your routine care. This would include
- Having tissue samples (biopsies) taken during a routine endoscopy
- Giving permission for the team to use tissue removed during surgery
- Giving extra blood samples during routine blood tests
The study team will look at your medical notes to gather information about your cancer, including your diagnosis, treatment and outcome. They will treat this information anonymously, so no one will be able to link it to you.
The team will also ask if you would be willing for them to contact you again in the future, in case they need to collect more samples or information related to this study. Or, to ask if you would be happy to take part in any new studies in the future. You do not have to agree to this if you don’t want to.
Hospital visits
You will not have to make any extra hospital visits to take part in this study.
Side effects
As the treatment and tests you have will be no different to those you would have had if you were not taking part, there are no extra side effects.
You will already be having biopsies taken. As the risks linked with taking these biopsies is very small, any extra risk from taking between 3 and 6 extra biopsies for the study would be almost none.
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 Rebecca Fitzgerald
Supported by
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Oesophageal Cancer Clinical and Molecular Stratification Group (OCCAMS)
Other information
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040