A study of 2 tests to find out if they can predict if early rectal cancer will come back after treatment (Ploidy and stroma study)

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

Cancer type:

Bowel (colorectal) cancer
Rectal cancer

Status:

Closed

Phase:

Other

This study is looking at 2 tests using tissue samples to help predict the chances of rectal cancer coming back after treatment. Rectal cancer is also known as cancer of the rectum (back passage). 

More about this trial

It is important to know how advanced a cancer is. This is called staging. The stage of a cancer tells you how big it is and how far it has spread. It helps your doctor decide which treatment you need. For example, the type of surgery you should have and if you need more treatment afterwards.
 
There are several tests to help to work out the stage of the cancer and predict how well treatment will work for rectal cancer. These include routine scans and analysing tissue samples (biopsies) Open a glossary item taken during surgery. But doctors are looking at ways to improve on this information. 
 
In this study, they are looking at 2 extra tests called, the:
  • ploidy test
  • stroma test
Ploidy is the number of sets of chromosomes Open a glossary item in a cell. Cancer cells may have an abnormal number. And in some types of cancer it can mean people have a worse outcome after treatment. 
 
Stroma measures the amount of tumour compared to supporting tissue in the cancer. 
 
The researchers use tissue samples taken during surgery to do the extra tests. These tests are already used for some other types of cancer and give information about how aggressive the cancer is and how likely it is to come back. 
 
The aims of the study are to:
  • help work out the best treatment
  • find out if the extra tests can help predict how well people do after treatment
  • better predict whose cancer might come back 
Please note – taking part won’t change your treatment in any way. But it might help people with rectal cancer in the future.
 

Who can enter

The following bullet points list 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 all of the following apply. 
You:
  • have rectal cancer that can be removed with surgery
  • can read and write in English
  • are due to have or have had a type of surgery called trans anal endoscopic microsurgery (TEM)
  • are at least 18 years old
 
Who can’t take part 
You cannot join this study if there isn’t a suitable tissue sample (biopsy) available after surgery for the study team to do the tests.
 

Trial design

The study team hope 150 people will take part in the study. It is for people having treatment at Oxford University Hospitals NHS Foundation Trust.

Some people might have already had surgery when they join the study. Or you might be due to have your routine surgery. 

The surgeon takes the tissue sample during the operation. They send it to Norway to a specialist laboratory for the extra tests. 

The trial team will compare the results from these 2 tests with other information about the cancer and how people do for at least 2 years after surgery. 

Hospital visits

You don’t have any extra hospital visits if you take part in this study. 

Side effects

There are no extra side effects if you take part in this study.

We have more information about surgery for rectal cancer.

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Mr Chris Cunningham

Supported by

Oslo University Hospital 
OCCTOPUS – Oxford Colon Cancer Trust 
Nuffield Department of Surgical Sciences
Oxford University Hospitals NHS Trust

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15468

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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