The Symptoms of Colorectal Cancer Evaluation Research (SOCCER) study is a clinical study using information collected on people who have symptoms that could be caused by bowel cancer and have been referred by their doctor for further tests.
It is hoped that the results of the SOCCER study will be used to inform the national clinical guidelines that advise doctors on which test to use in patients with symptoms that could be caused by bowel cancer. This study is funded by the National Institute for Health Research Health Technology Assessment (NIHR-HTA) programme.
Note: In July 2019, we became aware that two versions of the SIGGAR consent forms were used. The first version of the consent form did not include the option for participants to consent to the use of their data in future research. Of the 5,384 people who were randomised to SIGGAR and did not subsequently withdraw consent, we estimate that 1,890 people completed the first version of the consent form. However, the SOCCER study protocol and all supporting documents only referred to the second version of the consent form that, in addition to consenting to take part in the SIGGAR trials, also gave an option for participants to consent for their data to be used in future research. All data analysed for the SOCCER study was done in a way that no individual could be identified by the study team at the CSPRG. All results from the SOCCER study were published in such a way that no one could be identified (anonymised, aggregated tables). The North East-York Research Ethics Committee have been informed.
Our Data Protection and Privacy Notice
This privacy notice explains your rights to your personal information, what you can expect us (the Cancer Screening and Prevention Research Group) to do with your personal data and our lawful basis for doing so. This notice also explains who you should contact if you have any queries or complaints about how we are processing your personal data.
Under the 2018 General Data Protection Regulation (GDPR) and accompanying Data Protection Act (2018) ‘personal data’ is any data that can be linked to an identifiable individual (for a full definition see: Information Commissioner’s Office (ICO) website: What is Personal Data?). Some types of personal data, such as health data, are additionally classified as ‘special category personal data’. The law considers special category personal data to be more sensitive and gives it more legal protection (for more information see: ICO website: Special Category Data). As the Cancer Screening and Prevention Research Group processes (processing is the term used to refer to collecting, analysing and storing data) health data, much of the personal data we hold is considered to be special category personal data.
Who is responsible for the lawful processing of your personal data?
The GDPR and Data Protection Act define roles and responsibilities for those involved in processing personal data.
The Cancer Screening and Prevention Research Group (hereafter; CSPRG) are a research group at Imperial College London. The CSPRG can be contacted via the ‘Contact Us’ page on this website. The data controller determines the purpose for which and the manner in which personal data is to be processed see ICO website: Controllers and Processors. For the personal data held by the CSPRG, the data controller is Imperial College London. The data controller’s representative for our data is the Director of Information Governance for Academic Health Sciences. All queries relating to the handling of personal data should be directed to the Imperial College London Data Protection Officer via email at firstname.lastname@example.org. Contact details can also be found at the end of this privacy notice.
Why are we processing personal data?
The research focus of the CSPRG is bowel cancer, also known as colorectal cancer. In the UK, every year over 41,000 people are diagnosed with bowel cancer and 16,000 people die from this disease. Through our research we hope to reduce the number of people being diagnosed with bowel cancer and dying from this disease. Much of our work focuses on how to help make bowel cancer screening and surveillance programmes more effective and acceptable for patients, and more efficient for the NHS, and other health services internationally. To understand the effectiveness of bowel cancer screening and surveillance programmes, we conduct large scale studies on procedures conducted and the benefits to patients. Identifiable patient data are usually necessary to track long-term health outcomes from participants enrolled in our studies. The CSPRG therefore needs to collect and hold personal data – often special category personal data. Our more specific purposes for processing data for each of our studies are detailed on the ‘Studies’ pages of our website.
What personal data do we have?
The personal data we hold is special category personal data relating to individual health. For example, for several of our studies we analyse procedure and treatment information, information about cancers occurring, whether they progress and the patients’ long-term health outcomes. In addition, we also often require some basic information about patients such as age and gender to inform our analysis. The full details of the personal data processed for each of our studies can be found on the ‘Studies’ pages of our website.
To fulfil our research aims we obtain personal data from a variety of sources. Much of our data is either obtained directly from NHS Trusts, or via third parties such as NHS Digital, the Office for National Statistics, the Bowel Cancer Screening Programme, National Cancer Registries (including the Welsh Cancer Intelligence and Surveillance Unit) and Information Services Division Scotland, part of NHS National Services Scotland. More detailed explanations of our sources of data can be found on the ‘Patient Data’ page and ‘Studies’ pages of our website.
Where data has been obtained from third party data providers under section 251 approval, national data opt-outs have been applied by the provider since 2016.
How do we process personal data?
All personal data we hold are processed in secure systems. For each active study we have completed a Data Protection Impact Assessment that has been approved by the Head of the CSPRG (as the Information Asset Owner) and the Imperial College London Data Protection Officer. No processing performed by the CSPRG involves automated decision-making or profiling. Unless stated otherwise on the ‘Studies’ pages of our website, all personal data are processed exclusively by the CSPRG. None of our studies process or transfer personal data outside the UK.
The Imperial College Data retention schedule mandates that data is retained for ten years after the end of a study (see the College Retention Schedule here). The expected end of these ten year retention periods for each of our studies are listed under the ‘Studies’ pages of our website under the ‘How long will we retain the data?’ sections.
What is our lawful basis for processing personal data?
Processing personal data requires justification under two legal frameworks: the GDPR/Data Protection Act 2018 and under the common law duty of confidentiality.
Article 6 of the GDPR lays out six valid bases under which personal data can be processed lawfully. We process personal data under lawful basis 6(e) ‘Public task’ as: processing is necessary for the performance of a task carried out in the public interest. We are also required to have a separate lawful basis for processing the more sensitive special category personal data. Our legal basis for processing special category personal data is Article 9(j) ‘processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes […]’
In addition, health data (such as that the CSPRG hold) require a separate lawful basis under the common law duty of confidentiality. In some of our studies, patients consented to be part of the study and for the CSPRG to process their data. In other studies, consent could not be sought due to practical considerations or the nature of the study. In these studies, we have obtained lawful permission to obtain and process personal data under section 251 of the National Health Act 2006. The common law legal bases for data processing in each study are explained in the ‘Studies’ pages of our website under the ‘What approvals has the study received?’ sections.
What are your rights concerning your personal data?
The GDPR grants individuals several rights concerning their personal 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 or by contacting the Imperial College London Data Protection Officer via email at email@example.com. 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 the Information Commissioner’s Office.
Where can you direct queries or complaints?
Please be aware that individuals also have a right to complain to a supervisory authority- in this case the Information Commissioner’s Office (ICO) – if they feel their data is being used unlawfully. The ICO does recommend that you seek to resolve matters with the data controller – for our data that is Imperial College London – before contacting the commissioner’s office. 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 data, 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 Data Protection Officer, Faculty Building Level 4, Imperial College London, 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 raise your complaint with the Information Commissioner’s Office.
Information relating specifically to the SOCCER and SIGGAR studies
The CSPRG at Imperial College London processes special category personal data for the SIGGAR and SOCCER studies. SIGGAR and SOCCER are two closely linked projects aimed at reducing colorectal cancer incidence and mortality. SIGGAR involved two randomised controlled trials to compare the efficacy of Computed Tomographic Colonography (CTC) to two established examination techniques: colonoscopy and barium enema to examine patients with symptoms requiring a whole-colon examination. The SOCCER study used data gathered during the SIGGAR trials to investigate the potential efficacy of flexible sigmoidoscopy (a technique which examines only the last [distal] part of the colon) as an alternative to whole-colon examination. To fulfil the aims of the study and understand the long-term effectiveness of the different examination techniques, the CSPRG processes special category personal data to track the long-term health outcomes of study participants. The special category personal data used in this study is crucial to the success of this project, and the public good generally.
Imperial College London (the data controller for data processed by the CSPRG, see above) are the recipient of data for the SIGGAR and SOCCER studies. The special category personal data for these studies is received by the CSPRG from several sources.
1. NHS Hospital trusts in England and Scotland
The CSPRG received demographic information, symptom information, consent forms, trial-linked clinical notes and treatment data about patients in the SIGGAR and SOCCER studies directly from the 21 hospitals in which the SIGGAR trials were conducted. The 21 participating hospitals were:
- Bradford Hospital
- Frimley Park Hospital
- Charing Cross Hospital
- Hammersmith Hospital
- St Marys Hospital
- Leighton Hospital
- University Hospital of North Tees
- St Marks Hospital
- Nottingham City Hospital
- Nottingham Queens Medical Centre
- Oxford Radcliffe Hospital
- Royal Oldham Hospital
- Derriford Hospital
- Queen Alexandra Hospital
- Royal Cornwall Hospital
- Royal United Hospital
- Withington Hospital
- Wythenshawe Hospital
- Queen Elizabeth Hospital
- Furness General Hospital
- Royal Lancaster Infirmary
NHS Digital collect and process data from across the health and social care system in England. NHS Digital provide cancer and deaths data about patients enrolled in the SIGGAR and SOCCER studies to the CSPRG. NHS Digital receive some of this data from the Office for National Statistics.
The Office for National Statistics process cancer and deaths data for patients in England. The Office for National Statistics provided this information to the CSPRG for the patients in this study. The data were passed to the CSPRG via NHS Digital.
The research team working on the SIGGAR study have access to the identifiable special category personal data for patients enrolled in the trials. The SOCCER study team only have access to pseudonymised data for the patients included in the SOCCER study. Pseudonymised data (see also GDPR Article 4.3) are personal data that can no longer be attributed to a specific individual without additional information. In this case, the SOCCER database does not contain any easily identifiable information such as names or NHS numbers.
The SIGGAR study was performed in collaboration with researchers at University College London (UCL) and the University of Birmingham. The main analysis for the SIGGAR study was done in collaboration with researchers at UCL who received subsets of the data to answer specific research questions. Researchers at UCL also received a pseudonymised subset of the data to perform a Health Psychology Assessment. Researchers at the University of Birmingham received a pseudonymised subset of the data to perform a Health Economics Analysis. Both groups received only pseudonymised data and therefore could not link the data they received to identifiers such as names and NHS numbers.
What were the aims of the SOCCER study?
Flexible sigmoidoscopy, which is an examination of the lower part of the bowel, has many potential benefits over tests that examine the whole of the large bowel, both for patients – who may find it more acceptable – and also for health services – that need to ensure resources are being used in the most effective way.
Prior to the SOCCER study, Professor Michael Thompson, colorectal surgeon, and Karen Thompson, epidemiologist, both from Portsmouth had carried out a study which showed that certain bowel cancer signs and symptoms are more common in people with bowel cancers in the lower part of the large bowel, and so within reach of the flexible sigmoidoscopy, and that other symptoms are more common in people with cancer in parts of the bowel that are out of reach of the flexible sigmoidoscopy. This was a study at only one hospital, but it provided early evidence that specific signs and symptoms could be used to predict when flexible sigmoidoscopy could be a safe and effective test to diagnose bowel cancer, and when it is less likely to be effective.
The SOCCER study follows on from this work on bowel cancer symptoms. We are aiming to provide evidence that is needed to show whether flexible sigmoidoscopy is an effective and safe alternative to whole colon examinations for many people. If our results confirm the earlier study, we anticipate that this will change how doctors diagnose bowel cancer in their patients based on their symptoms.
What type of study is SOCCER?
SOCCER is a retrospective, observational analysis, which means it is looking at information from events that have already happened. In this instance, we are using information collected as part of the Special Interest Group Gastrointestinal and Abdominal Radiologists (SIGGAR) study to answer a different research question.
What is flexible sigmoidoscopy and how is it different to an examination of the whole large bowel (colon)?
When a person visits their doctor with symptoms that could be caused by bowel cancer they might be offered a test that can examine the whole large bowel (the colon) in order to detect abnormalities. This ‘whole colon’ examination is most likely to be a colonoscopy, a ‘virtual colonoscopy’ or a barium enema.
Colonoscopy is a procedure during which, usually under sedation, a tube (endoscope) with a small camera attached is inserted into the rectum and guided through the large bowel to examine its surface for abnormalities. Virtual colonoscopy is a newer test and uses x-rays to give 3-D images of the bowel. The barium enema examination involves passing a white liquid containing barium into the bowel through the rectum and then taking x-rays of the bowel.
Flexible sigmoidoscopy can also be used to examine the large bowel. Like colonoscopy, flexible sigmoidoscopy involves inserting a flexible tube into the rectum. However, unlike colonoscopy and virtual colonoscopy, flexible sigmoidoscopy is used to examine the lower part of the large bowel and the rectum only, and is not used to examine the whole colon.
Flexible sigmoidoscopy has several advantages over whole colon examinations. In particular, people do not need to complete a full bowel preparation before the procedure. Bowel preparation involves temporary dietary restrictions and taking laxatives to clear the bowel – some people find this difficult or inconvenient and it is also not suitable for everyone. People also do not need to be sedated for flexible sigmoidoscopy, which is generally required for colonoscopy. Some people find sedation an inconvenience because they are unable to return to work immediately, and it is also linked to a higher risk of complications.
When and where did the study take place?
Information for the SOCCER study has been collected from people who were registered as being potentially eligible for the SIGGAR study. People were recruited to the SIGGAR study from 21 NHS hospitals across England between March 2004 and December 2007 as shown below.
Who is included in the study?
Information for the SOCCER study has been collected from approximately 7,472 men and women who:
- were aged 55 years or over between March 2004 and December 2007 and
- were referred to one of the 21 participating NHS hospitals with bowel cancer symptoms at the time of the SIGGAR randomised-controlled trials and
- were registered as potentially eligible for the SIGGAR randomised-controlled trials.
The study group includes:
- 5,384 people who were randomised and consented during SIGGAR study (including consent for future research) and
- 2,088 people who had symptoms suggestive of bowel cancer but were not randomised to the study as a result of clinician preference. These patients were never approached about the SIGGAR study.
What type of information does the CSPRG hold for the purposes of the SOCCER study?
The CSPRG only holds personal information (such as name, full date of birth, NHS number) for the SOCCER patients if they were randomised on the SIGGAR study and the patient did not subsequently withdraw their consent. We do not hold any identifiable data for the remaining patients in the SOCCER cohort.
Additionally, all the data held on the SOCCER database is de-identified and we hold:
- clinical data including data on bowel symptoms, examinations;
- cancer and mortality data from NHS Digital
We completed data collection in November 2015. The patient data page provides further details on what information we hold for the purposes of our research, and how we use and protect this information.
What approvals has this study received?
This study was reviewed and approved by an independent ethics committee and other organisations with responsibilities for NHS patients and research in the NHS as follows:
- Northern and Yorkshire Multicentre Research Ethics Committee.
- Section 251 approval from Patient Information Advisory Group (PIAG), the National Information Governance Board (NIGB), predecessors of the Confidentiality Advisory Group (CAG) and CAG itself.
- Research and Development approval from the NHS Trusts managing all hospitals involved in the study.
How long will we retain the data?
Data collection for this study ended in November 2015. It is a requirement of Imperial College London, the organisation responsible for this study, that we hold data from all clinical trials for 10 years after the study end date. We therefore plan to hold the data for this study until November 2025.
What are the results of the study and what impact have they had?
The SOCCER study has been completed and we are in the process of publishing our results.
Our findings will be used to inform the guidelines – both in the UK and internationally – that advise doctors on the best test(s) for their patients. We hope that our findings will help ensure that patients receive the test(s) that most benefits them, and also generate efficiency savings for health services.
Some of the results of the SOCCER study have recently been published in the British Journal of Cancer. We have also produced a report for the National Institute for Health Research.