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

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 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 will complete our data collection by 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?

This study is due to end 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 is on-going and is due to be completed at the end of November, 2015. We expect to publish the results in peer reviewed medical journals in 2016.

We will be able to fully assess the impact of the SOCCER study when we have the full 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.