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
In order to conduct our research Imperial College London is the data controller for personal information from health care records (also known as ‘special category’ data). We either obtain this data 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, part of NHS National Services Scotland This means that we are responsible for looking after your information and using it properly. The CSPRG intends to keep special category, personal data for 10 years after our studies finish, as per the Imperial College London data retention guidelines. Imperial College London, UK, is the sponsor for our studies.
Further information on Imperial College London’s retention periods may be found at https://www.imperial.ac.uk/media/imperial-college/administration-and-support-services/records-and-archives/public/RetentionSchedule.pdf.
A link to Imperial College London’s data protection webpage may be found at https://www.imperial.ac.uk/admin-services/legal-services-office/data-protection/. The CSPRG privacy notice, described here, is most applicable to the information provided by CSPRG study participants and therefore takes precedence.
Your rights / GDPR Individual Rights
Your usual statutory rights to access, change or move your information are limited, because of exceptions applicable to some types of research, and also because we need to manage your information in specific, lawful ways in order for the research to be reliable and accurate. To safeguard your rights, we will use the minimum personally-identifiable information possible.
The EU General Data Protection Regulation (GDPR) grants individuals several rights concerning their data:
- The right to object (to processing of the data)
- The right to correct (inaccurate or incomplete data)
- The right to erasure (also known as “the right to be forgotten”)
- The right to restrict processing (e.g. while the accuracy of the data is contested)
- The right to portability (to have a copy of any data you have provided to us)
- The right to access (to have a copy of data we hold about you)
- The right to withdraw consent (if you have previously consented to take part)
If you think that we might be processing your data and you wish to exercise any of the rights listed above, please get in touch using the details on the Contact Us page. Though it may not always be possible for us to fulfil your request, we will respond to your query within one month. For more information on your GDPR rights, please see guidance provided by Information Commissioners Office.
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 must ensure that it is in the public interest when we use personal data and special categories of personal data. Some of this data is from patients who have completed a consent form. Where consent could not be sought, approval for obtaining and processing data was provided under section 251 of the National Health Service Act 2006.
Health and care research should be in the public interest, which means that we must demonstrate that our research serves the interests of society. We do this by following the UK Policy Framework for Health and Social Care Research.
If you wish to raise a complaint on how we have handled your personal data or if you want to find out more about how we use your information, please contact Imperial College London’s Data Protection Officer via email at firstname.lastname@example.org, via telephone on 020 7594 3502 or via post at Imperial College London, Data Protection Officer, Faculty Building Level 4, London SW7 2AZ.
If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO). The ICO does recommend that you seek to resolve matters with the data controller (us) first before involving the regulator.
Privacy and data protection information relating specifically to the FIT for Follow UP study
The CSPRG has collected information about study participants of the FIT for Follow-Up study from the NHS England Bowel Cancer Screening Programme and participant completed questionnaires. This information includes participants’ name, address, date of birth and health information, which is regarded as a special category of information. We will use this information to investigate whether a Faecal Immunochemical Test (FIT), once a year, to people with one large or 3–4 small polyps found at colonoscopy (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.
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.