Research Project: Helicobacter pylori screening study: a randomised stomach cancer prevention trial

Why are we doing the trial?
Lifelong infection of the stomach with the bacterium Helicobacter pylori (H Pylori) increases the risk of stomach cancer. The aim of this trial was to determine whether screening and treatment of H Pylori infection in middle age can reduce the risk of stomach cancer.

Who is in the trial and what did participation involve?
62,454 men and women attending ten BUPA Wellness Centres in Britain from 1997 to 2006 for a medical examination were recruited and randomly allocated into equally sized screened and control groups according to week of attendance. Those attending in screened weeks were offered serological testing for H pylori and, if they were positive, a one-week course of eradication treatment. Blood was collected and the serum stored from all participants (screened and control).

What are we doing now?
Information from death certificates and cancer registrations are received regularly from NHS Digital on all trial participants. When over 120 participants have developed stomach cancer (originally estimated to occur in 2022, after about 25 years follow-up) the serum samples from all persons who developed stomach cancer will be tested for H. pylori. The final comparison will be between the incidence of stomach cancer in the screened and control groups among H pylori positive persons only (rather than all persons).

How will the results of the trial influence current practice?
If the trial showed that all, or a substantial part of the excess risk of stomach cancer due to H Pylori infection can be reduced, it would mean that most cases of stomach cancer in the world could be prevented – a major public health finding. Findings of the trial will be presented to the National Screening Committee, who will determine if the evidence is sufficient to consider a national program of screening for stomach cancer in England.

Who do we share your information with?
Data will not be shared with anyone outside the immediate research team

How long will we keep your information for?
Your information will be retained for a period of 24 months after completion of the Helicobacter pylori screening study and then deleted unless there is a reason to retain it for longer.

Additional Information:
The privacy notice for this trial is at : https://www.sgul.ac.uk/privacy
If you require additional information about the trial please contact Professor Joan Morris from the Population Health Research Institute, St George’s, University of London, Cranmer Terrace SW17 0RE. Email : jmorris@sgul.ac.uk

What your rights are?
The Helicobacter pylori screening study is a research project carried out in the public interest. Therefore your rights to access, change or move your information are limited, as we need to manage the data in specific ways in order for the research to be reliable and accurate. If you withdraw your consent to participate in a research project, this will not mean we will have to remove all data as well. We will keep the information about you that we have already obtained to ensure research integrity is maintained in the public’s interest. To safeguard your rights, we will strive to use the minimum personally-identifiable information possible.

How to make a complaint?
St George’s, University of London (SGUL) is the ‘Data Controller’ of your personal data and are registered with the Information Commissioner’s Office (ICO) for the purposes of UK data protection legislation, registration number Z5770328.

The University has a Data Protection Officer who can be contacted at:
Email: dataprotection@sgul.ac.uk
Tel: 020 8725 0668
Address: Data Protection Officer, Information Services, St George’s University of London, Cranmer Terrace, LONDON SW17 0RE

If you are unhappy with the way in which your personal data is being processed you may, in the first instance, lodge a complaint with the University Data Protection Officer using the contact details above.
If you continue to have concerns thereafter you have the right to contact the Information Commissioner for a decision. The Information Commissioner can be contacted as below
Helpline: 0303 123 1113
Website: https://ico.org.uk/global/contact-us/