A study to understand more about stem cells in the bowel

Please note this trial is no longer recruiting patients.

This study is looking at the number and position of stem cells in bowel tissue of people at normal and high risk of bowel cancer.

A stem cell is a special cell that is able to grow into any type of cell in the body. They are in all tissues of the body, and help the body maintain itself by developing into specialised cells wherever they are needed.

Stem cells in the bowel are found at the bottom of thousands of glands (crypts) in the bowel lining. These stem cells create all the cells lining the bowel wall. The stem cells are created at the base of the crypt, and gradually rise to the top of the crypt, developing into fully mature bowel wall cells as they go.

Researchers now believe that bowel cancer cells come from stem cells where there has been some kind of gene fault to do with the growth and division of the cell. This leads to uncontrolled production of cells which in turn have faulty gene information, causing a cancer to form.

In this study, researchers want to understand more about stem cells in the bowel. They will look at tissue samples from people at normal risk of bowel cancer, and of those at higher risk. The aims of this study are to

See how many bowel stem cells there are in the samples
See where stem cells are in the bowel, and see if positions are different in the normal and high risk groups

You will not get any direct benefit from taking part in this study, and it is unlikely to change your treatment plan in any way. But the results of the study will be used to help people in the future.

Recruitment

Start 01/03/2010

End 27/05/2011

Phase

Other

Who can enter

You can enter this study if you are

Under the care of Wansbeck General Hospital or North Tyneside Hospital
Due to have a camera examination of the inside of your bowel (colonoscopy) or flexible sigmoidoscopy
Between 18 and 85 years of age

You cannot enter this study if you

Have a rare inherited disease that causes lots of non cancerous growths in the bowel (familial adenomatous polyposis (FAP)
Have a rare inherited condition called HNPCC (Lynch syndrome) that increases risk of bowel cancer, womb cancer, ovarian cancer and stomach cancer
Have cancer of the bowel (colorectal cancer)
Have had surgery to remove part of your bowel (colorectal resection)
Have had chemotherapy in the last 6 months
Are taking aspirin or other non steroidal anti inflammatory drugs (NSAIDs)
Are taking any other medication that dampens your immune system
Are pregnant

OR (during your colonoscopy or flexible sigmoidoscopy)

The doctor could not examine all the bowel tissue they needed to
The doctor found bowel cancer
Part of your bowel tissue tore (perforated) during the examination

The study team would not be able to use any samples taken if the laboratory later finds bowel cancer cells or tiny areas of inflamed bowel tissue (colitis).

Trial design

This study will recruit 150 people. Everyone taking part will have the bowel examination that is part of their planned treatment.

For the study, you will give permission for the team to remove 9 small samples of bowel tissue (biopsies) during your colonoscopy or flexible sigmoidoscopy.

Hospital visits

As the study team will be taking the tissue samples during your planned bowel examination, you will not need to make any extra visits to take part in this study.

Side effects

All operations and procedures carry a small risk.

There is a very small chance that the colonoscopy or sigmoidoscopy could cause a hole in the bowel wall (a perforation). A perforation will almost always need surgery to fix it.

Bleeding from the bowel is a more common complication, but this is usually minor, and settles on its own.

The more biopsies you have, the higher the risk of bleeding or perforation.