THIS INFORMATION IS FOR PATIENTS THAT HAVE BEEN INVITED TO PARTICIPATE IN THE NICE FIT STUDY.
Why are we doing this study
At present, there is no easy test to detect bowel cancer. Patients with symptoms that might suggest bowel cancer are normally referred for an urgent camera test inserted into the bowel called colonoscopy. But only 4 out of 100 patients having a colonoscopy will have a diagnosis of bowel cancer. So a lot of patients are having a colonoscopy where the results will be negative. We do this to try and not miss any bowel cancer.
A new test called FIT (faecal immunohistochemistry test) has shown that it is very accurate at ruling out bowel cancer and other bowel disease.
Parts of the NHS in England, including London, have decided to start testing patients with bowel symptoms with FIT before deciding if they need a colonoscopy. We are working with the NHS and your local hospital to ensure that using FIT will not miss patients with significant bowel disease including cancer especially that previous work has shown that FIT results vary depending on age, sex, ethnicity and wealth.
What would taking part involve?
As you know, your GP has referred you to hospital with bowel symptoms. You will have already received or shortly be receiving an appointment for a colonoscopy examination. You will be asked to take bowel prep to clean the bowel before your colonoscopy. We would like you to give a stool sample at any time before you start taking the bowel preparation. The test cannot be done after you begin your bowel preparation. To give the stool sample, please follow the illustrated instruction leaflet in the bag with the kit. Once collected, please post to the lab for analysis, using the supplied self-addressed prepaid envelope. A member of the FIT team working with your hospital will be contacting you to go through the instructions of the kit and to answer any questions you may have.
What are the possible benefits of taking part?
The FIT test will not affect your colonoscopy results or any subsequent treatment. You will be receiving the gold standard investigation at this moment which is a colonoscopy. However, if we can prove the FIT test is fit for purpose, then you or people with similar symptoms could benefit when the test is introduced by the NHS later this year. A negative result from the FIT stool sample could rule out bowel cancer and prevent them from needing a colonoscopy. This will also save the NHS time and money from not having to carry out unnecessary colonoscopies.
What are the possible disadvantages and risks of giving a stool sample?
There are no risks to giving a stool sample.
What will happen if I don't want to give a stool sample?
You are free not to give a stool sample and this will not affect your treatment.
How will my information be kept confidential?
All of your personal details will be kept confidential. Your samples will be analysed at the Bowel Cancer Screening Hub in Guilford and will only be identified by a unique number. Your clinical information is stored in a secured database and coded in such a way as to make it impossible for you to be identified personally.
Do I need to sign a consent form?
No. Returning the kit in the post will be taken as your consent to take part in the study.
Why have you contacted me without my permission?
The Confidentiality Advisory Group (CAG) gave this work special permission due to its public importance. Selection is performed under the supervision of a lead specialist clinician at the local hospital. If you do not give a stool sample, all your details will be deleted from our records.
What will happen to the results of this work?
The results will be published and spread within the NHS. A summary leaflet will be available once the work is completed on this website.
Who is organising and funding this work?
The work is was initiated by the department of Colorectal Surgery at Croydon University Hospital and RM Partners Accountable Cancer Network in South and West London. NHS England are funding this study through RM Partners. Alpha labs is providing the FIT analyser, the FIT kit,. the raw materials and patient instruction leaflets.
What will happen to the stool sample I give?
Once your stool sample has been processed, it will be destroyed.
What do I do if I have further questions?
Please contact us.