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:
Status:
Phase:
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
- 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
- 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
- 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.
Hospital visits
There are no extra hospital visits as part of this study. You do the test at home and send it back to the trial team using a prepaid envelope.
Side effects
There are no side effects from FIT.
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
Mr Muti Abulafi
Supported by
Croydon Health Services NHS Trust
RM Partners
NHS England
NHS Bowel Cancer Screening Southern Programme Hub
Alpha Laboratories Ltd
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040