Follow up of H Pylori screening study
Research type
Research Study
Full title
Follow Up of Participants in the Randomised Trial of Helicobacter Pylori Screening (HPSS)
IRAS ID
136558
Contact name
Nicholas Wald
Contact email
Sponsor organisation
St George's, University of London
Research summary
Helicobacter pylori infection of the stomach accounts for most cases of stomach cancer worldwide. The risk of stomach cancer is about five times greater in infected than in uninfected persons. While the association is accepted as causal, it is not known whether screening and treatment of the infection in middle age can reverse this excess risk.
A randomised controlled trial was set up to answer this question. Recruitment for the trial was from 1997 to 2006
during which 62,454 people attending ten BUPA Wellness Centres for a medical examination were randomly allocated
into 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 stored from all participants (screened and control). All participants were flagged with Health and Social
Care Information Centre(HSCIC) and information on their deaths and cancer notifications has been supplied to the PI
(Professor Sir Nicholas Wald) since 1997.
It was expected that the length of follow-up would be a minimum of 20 years. Due to changes in the regulations
concerning the provision of data on mortality and cancer registrations by the Data Access Request Service (DARS) -
NHS Digital, we need new are applying to the HRA for permissions to continue to receive this information. To obtain
these permissions we require ethics permission to This protocol therefore covers only the receipt, processing and
analysis of the mortality and cancer registration information and the final biochemical analysis of the stored serum
samples.The original ethics permission for the trial was given by the Royal College of General Practitioners Research
Ethics Committee in 1995 : CREC/1995/33(28). This committee no-longer exists.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
17/NW/0681
Date of REC Opinion
28 Nov 2017
REC opinion
Favourable Opinion