SOCCER


SOCCER

SOCCER study

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 .

As SOCCER is closely linked to the SIGGAR trial, it has the same ISRCTN registration; 95152621.

Our Data Protection and Privacy Notice

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.

Legal Basis

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.

Contact us

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 dpo@imperial.ac.uk, 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 SOCCER and SIGGAR studies

The CSPRG has collected information about the study participants of the Symptoms of Colorectal Cancer Evaluation Research (SOCCER) study from the 21 NHS hospitals across England and NHS Digital, including data from the Office for National Statistics. This information includes name, date of birth, NHS number for the participants who consented to the predecessor SIGGAR study and health information, which is regarded as a special category of information. We will use this information to investigate whether flexible sigmoidoscopy is an effective and safe alternative to whole colon examinations for some people. If our results confirm an earlier study conducted at a single hospital, we anticipate that this will change how doctors diagnose bowel cancer in their patients based on their symptoms.

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 in to 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.

SIGGAR_HOSPITALS

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.