Randomised trial of H Pylori screening for the prevention of stomach cancer
Background and study aims
Helicobacter pylori is a bacterial infection that increases the risk of stomach cancer. The aim of this study is to find out whether screening for and eradicating H. pylori infection in healthy middle aged people can reduce the subsequent incidence of stomach cancer.
62,454 men aged 35-69 and women aged 45-69 who attended a Bupa Wellness Centre for a health screen between July 1997 and January 2006.
What did the study involve?
Participants were randomly allocated to one of two groups. Participants in one group were tested for H. pylori and, if found to be infected, were offered a one-week course of drug treatment to eradicate the infection (oral metronidazole, clarithromycin and lansoprazole). Participants in the other group did not receive any screening or treatment. Death certificate and cancer registrations are received from NHS Digital on all participants to assess the incidence of deaths from stomach cancer.
When is the study starting and how long is it expected to run for?
April 1997 to January 2030
Cancer Research UK (CRUK) are currently funding this follow-up stage of the trial.
Personal Information stored in the Randomised Trial of H Pylori Screening
- The H Pylori database is stored at The Wolfson Institute, Queen Mary University of London.
- The Data Controller for the database is Queen Mary University of London
- The data protection officer of the data controller is Mia Kalezic (email@example.com)
- Article6(1)(e) of the General Data Protection Regulation provides the legal basis for public authorities (e.g. universities and NHS organisations) to process personal data for research purposes.
- The processing of identifiable personal data is to determine if eradication of H Pylori infection in middle age reduces the risk of stomach cancer developing.
- A team of researchers, led by Professor Sir Nicholas Wald, at Barts and the London School of Medicine and Dentistry, Queen Mary University of London collected data from 62,454 men aged 35-69 and women aged 45-69 who attended a Bupa Wellness Centre for a health screen between July 1997 and January 2006.
- The data collected from the questionnaires completed by the participants included personal names, gender, date of birth, NHS number, participant’s address at the time of screening and the participant’s GP contact details at the time of screening.
- Participant identifiers were sent to NHS Digital at the time of recruitment so that the cohort could be flagged for ongoing follow-up
- Mortality and cancer registration data will be received from NHS Digital about all participants – the data will include personal identifiers
- Personal identifiers are stored on a secure server and are used by the database manager only to ensure that any subsequent information from cancer notifications or mortality is linked to the correct person.
- Personal identifiers are not released to any researchers or other people.
- Non-identifiable data may be shared in the future if there is a scientifically valid reason to do so and the researchers requesting the data can demonstrate that they will keep the data securely and not release any potentially identifiable data.
- Data from cancer notifications or mortality will continue to be collected until there is sufficient power in the study to compare the screened and unscreened groups. Once this has occurred the data will be retained for a minimum of ten years and will only be destroyed once it is judged that it has no scientific value.
- Participants in the randomised trial of H Pylori screening may request that their data are erased from the study. However this request may not be granted if it would seriously impair the analysis of the results from the study. If you wish your information to be removed please contact: Professor Joan Morris by email (firstname.lastname@example.org) or phone (02078826274) to discuss potential solutions.
- Participants have the right to access their data and the right to rectify it if it is inaccurate. If you wish to do so please contact: Professor Joan Morris by email (email@example.com) or phone (02078826274).
- Participants who wish to complain about the use of their data by this study may do so by contacting the Information Commissioners Office (ICO) (https://ico.org.uk/make-a-complaint/)