FIT for Follow-Up


FIT

FIT for Follow-Up study

The FIT for Follow-Up study was started in 2012, recruiting almost 6,000 men and women. It is currently in the analysis and write-up stage. We hope that the results from this study will be used to inform the NHS Bowel Cancer Screening Programme, and to benefit people found to have adenomas requiring follow-up in the future. This study is funded by the Department of Health, through the National Institute for Health Research Health Technology Assessment programme.

The Fit for Follow-Up study also has its own website: www.fit4followup.org.uk.

The trial is registered with the ISRCTN registry. Its unique number is 18040196.

Our Data Protection and Privacy Notice

Imperial College London is the sponsor for the studies run by the Cancer Screening and Prevention Research Group (CSPRG). We will be using special category, personal information from health care records, either directly from NHS Trusts or via third parties such as NHS Digital, the Office for National Statistics, National cancer registries, including the Welsh Cancer Intelligence and Surveillance Unit, and Information Services Division (Scotland), in order to undertake these studies where we will act as the data controller. This means that we are responsible for looking after your information and using it properly. CSPRG / Imperial College London will keep special category, personal data about you for 10 years after the study has finished.

As a University we use personal data and special categories of personal data to conduct research to improve health, care and services. As a publicly-funded organisation, we have to ensure that it is in the public interest when we use personal data and special categories of personal data from people who have agreed to take part in research or where we have section 251 approval to obtain, process and hold such data.

Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

Health and care research should be in the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research.

When you agree to take part in a research study, the information about your health and care may be provided to researchers running other research studies in this organisation and in other organisations. These organisations may be universities involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research.

This information will not identify you and will not be combined with other information in a way that could identify you. The information will only be used for the purpose of health and care research, and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance.

You can find out more about how we use your information by contacting us directly – our contact details are available here, or by contacting the Data Protection Officer for Imperial College London at: dpo@imperial.ac.uk .

Further information can be found via the Imperial College London webpages:

http://www.imperial.ac.uk/admin-services/legal-services-office/data-protection/

http://www.imperial.ac.uk/admin-services/legal-services-office/data-protection/processing-personal-data/research-data/

 

 

What are the aims of the FIT for Follow-Up study?

In the English NHS Bowel Cancer Screening Programme, men and women aged 60–74 years old are invited to participate in screening for bowel cancer every two years. At present, people are asked to complete a simple stool test (the guaiac Faecal Occult Blood test, gFOBt), which is sent to them in the post to be completed at home. People who have an abnormal test result (traces of blood are found in the stool) are invited for an examination of their large bowel to identify the source of the blood loss. Usually this examination is a colonoscopy, which is carried out by a specialist doctor or nurse in a hospital. One in every 5 people who have their colonoscopy, will have large (1cm across or larger) or multiple polyps found. It is known that people with large or multiple polyps are at higher risk of developing more polyps or bowel cancer in the future; for people with one large or 3–4 small polyps, this risk is classed as ‘intermediate’. Currently, it is recommended that everyone in the intermediate risk group is offered another colonoscopy after 3 years to look for polyps or early cancers – this is called a follow-up colonoscopy.

Although follow-up colonoscopy is the most effective way to protect people in the intermediate risk group from developing cancer, it is not perfect. Colonoscopy is uncomfortable, carries a small risk of complications, and is also demanding on health service resources. More effective, and more acceptable, alternatives to the 3-yearly follow-up colonoscopy are being sought.

The FIT for Follow-Up study is looking at whether offering a Faecal Immunochemical Test (FIT), once a year, to people in the intermediate risk group is an effective and safe alternative to 3-yearly follow-up colonoscopy. The study will also look at how acceptable the FIT is to this group of people as an alternative to follow-up colonoscopy, and whether it is a more effective use of health service resources. The FIT test is described below.

What type of study is the FIT for Follow-Up study?

The study will compare the accuracy of annual FIT testing with the results of the year 3 follow-up colonoscopy.

People who agreed to take part in our research project and provided their consent have been asked to complete a Faecal Immunochemical Test (FIT) once a year. If a FIT kit result is positive at any stage, the study participant is offered their planned 3-year follow-up colonoscopy immediately, rather than waiting until the third year. If a participant is negative at each FIT test, they will still be offered their 3-year follow-up colonoscopy, as part of standard care within the NHS Bowel Cancer Screening Programme. Similarly, anyone who did not choose to participate in this study will still be offered a 3-year follow-up colonoscopy as part of standard care within the screening programme.

There is a separate website for participants in the FIT for Follow-Up study which has further details of the study.

What is a FIT test (Faecal Immunochemical Test)?

FIT stands for Faecal Immunochemical Test. Like the guaiac Faecal Occult Blood Test (gFOBt) that is currently used in the NHS Bowel Cancer Screening Programme, this test is used to detect blood in the stool that is not visible to the eye (‘hidden blood’). Growths in the bowel, called ‘polyps’ or ‘adenomas’ can lead to small amounts of blood being lost in the stool as hidden blood. Bowel polyps are common and are not cancer, but they can develop into cancer over time so they are removed if they are found. Bowel cancer can also cause blood to be lost in the stool. The FIT kit is used to look for hidden blood in stool to determine whether an individual needs further examination, which can enable the removal of bowel polyps and identify bowel cancers at an early stage when they are much more likely to be successfully treated. The FIT kit can be sent in the post, is simple to do and can be completed at home.

When and where is the study taking place?

The FIT for Follow-Up study is taking place in England. It began in February 2012, and is not expected to be complete until the end of 2016. This study has now completed recruitment: no new invitations will be sent, but if you have received an invitation previously and not returned your test kit, you should be able to participate if you return the kit and consent form – please contact us if you have questions regarding this.

Who is included in the study?

We invited people to participate in this study through the NHS Bowel Cancer Screening Programme. People were eligible to be invited if they were between 60 and 71 years of age, had taken part in the NHS Bowel Cancer Screening Programme, and tested positive for blood in their stool, and subsequently had a colonoscopy at which one large polyp or multiple small polyps were found (and so were considered at intermediate risk).

What type of information does the CSPRG hold for the purposes of the FIT for Follow-Up study?

We invited approximately 8,000 eligible people from across England to participate in this study between 2012 and 2014. If you received an invitation to participate in the study, your details will be kept on a list of invited participants for the FIT for Follow-Up study that is held by the NHS Bowel Cancer Screening Programme. If you decided to participate and returned a consent form, your identifiable details will have been passed to the CSPRG and your data will be used in the study.

We hold identifiable information (including name, address and date of birth) and clinical information relating to bowel tests during the time period of the study.

What approvals has this study received?

This study received:

  • Ethics approval from the NHS Research Ethics Service (NRES) London – City and East committee
  • Section 251 approval from the National Information Governance Board (NIGB) Ethics and Confidentiality Committee (the predecessor of the Confidentiality Advisory Group)
  • Research and Development Approval from the Royal Surrey County Hospital NHS Trust

Why do we need to hold identifiable data for this study?

We need to use identifiable information for this study as we need to contact participants by mail throughout the study, and we need to request data on follow-up colonoscopies from the local bowel cancer screening centres.

How long will we retain the data?

The study is currently due to finish on 31st December 2016. It is a requirement of Imperial College London, which is the organisation responsible for this study, that we hold study data for 10 years after the end date. We therefore plan to hold the data for this study until December 2026.

What are the results of the study and what impact have they had?

The FIT for Follow-Up study completed in March 2017 and when the results have been analysed, the detailed findings will be published in peer-reviewed medical journals and on the NHS National Institute for Health Research website. A summary of the findings will also be placed on this website.