A study looking at a new test called FIT to look for signs of bowel cancer (NICE FIT)

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

Cancer type:

Bowel (colorectal) cancer

Status:

Closed

Phase:

Other

A study to see if a new test called FIT can tell whether people with symptoms need to have a bowel test (colonoscopy) to look for signs of bowel cancer. FIT stands for faecal immunochemical test.

This study is also:

looking at bowel cancer DNA (biomarker sub study)
comparing the FIT test results from different brands (multisampling sub study)

Please note - the main part of this trial is now closed. Only the biomarker sub study and the multisampling sub study are open for recruitment.

More about this trial

You have a bowel test called colonoscopy if you have symptoms of bowel cancer. The doctor uses a flexible tube called a colonoscope to look at the inside of your bowel. But only a small number of people with symptoms have bowel cancer.

A new test called faecal immunochemical test (FIT) is currently being looked at to check for bowel cancer. FIT is a test that looks for tiny traces of blood in the poo (it’s a stool dipstick test). Blood in poo can be a sign of bowel cancer.

In this study, doctors want to find out if FIT can tell who needs to have a colonoscopy when they have symptoms. Everyone taking part has the FIT before having a colonoscopy and the results are compared. If the FIT results are correct, in the future you may only need to have a stool dipstick test to check for bowel cancer (rather than a colonoscopy).

The study team would also like to do 2 sub studies to:

look for bowel cancer DNA (this is the biomarker sub study)
compare the FIT test results from 4 different commercial brands (this is the multisampling sub study)

Please note - the main part of this trial is now closed. Only the biomarker sub study and the multisampling sub study are open for recruitment.

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 the following apply. You have possible symptoms of bowel cancer and:

are going to have a colonoscopy in the next 2 weeks (you were referred via the 2 week wait referral pathway)
are at least 18 years old

Who can’t take part

You cannot join this study if any of these apply:

you can’t have a colonoscopy for any reason
you can’t do the faecal immunochemical test (FIT) for any reason
your hospital is not recruiting people to this study

Trial design

Please note - the main part of this trial is now closed. Only the biomarker sub study and the multisampling sub study are open for recruitment.

Researchers hope that around 5,500 people from England will take part in this study.

You do the FIT at home, before having the colonoscopy. You are sent a kit and a leaflet which explains how to do the test. Once you have tested the poo, you send it to the laboratory using a prepaid envelope.

The colonoscopy you have is the same as if you weren’t taking part in this study. Your doctor or nurse can tell you what to expect. Taking part in this study will not delay you having the colonoscopy. The results of the FIT test will not affect your care or be given to you.

Biomarker sub study
Researchers need up to 2,000 people who are taking part in the main study, to join this sub study.

Everyone taking part has a blood test and gives a tissue sample. You give them when you are at the hospital having a colonoscopy.

Researchers want to look for bowel cancer DNA in your blood and tissue sample. This is called circulating tumour DNA.

Multisampling sub study
Researchers hope that between 500 and 1,000 people who are taking part in the main study will agree to join this sub study.

Everyone taking part gives 4 poo samples, instead of one. You are sent 4 kit tests from different brands. You do the test at home and send it back to the laboratory using the prepaid envelope. The study team will send you clear instructions on how to do the tests.

Researchers want to find out whether there are any differences between the 4 kit brands.