Multicentric Randomized Study of H. Pylori Eradication and Pepsinogen Testing for Prevention of Gastric Cancer Mortality
Status:
Recruiting
Trial end date:
2035-12-01
Target enrollment:
Participant gender:
Summary
Currently no ideal preventive modalities are available for reducing gastric-cancer caused
mortality in organized population-based application. The primary objective of the study is to
determine if H.pylori screening followed by eradication of positive subjects and endoscopic
follow-up of those with serological evidence of atrophic gastritis reduces mortality from
gastric cancer in middle-aged people in high-risk areas. The GISTAR study is a multicenter
randomized study of H.pylori eradication and pepsinogen testing for prevention of gastric
cancer mortality. Altogether 30.000 individuals aged 40-64 years will be enrolled, providing
90% study power to detect at least 35% reduction in gastric cancer mortality at 15 years of
follow-up. Participants will be randomly allocated to one of two groups. In the active
investigation/management group those positive for H.pylori will be offered eradication
therapy and individuals with decreased pepsinogen I/II ratio will be invited for endoscopy.
The control group will receive standard health care. The primary endpoint for this trial will
be the mortality difference from gastric cancer between the two groups at 15 years or when
enough cases accumulate to demonstrate a statistical difference. The study is expected to
provide valuable information on the utility for reduction in gastric cancer mortality of: 1)
H.pylori eradication in adults on a population-basis, including subjects who may already have
pre-malignant lesions; and 2) pepsinogen testing in screening settings. A pilot study of
3,455 individuals prior to the main trial was conducted from October 2013 to December 2016.
Phase:
Phase 4
Details
Lead Sponsor:
International Agency for Research on Cancer
Collaborators:
4Pharma Ltd. Academic Histology Laboratory (Latvia) Academic Histology laboratory, SIA, Latvia Karolinska Institutet Research institute for Nordic Nations, Krasnoyarsk, Russia Research Institute of Internal Medicine, Novosibirsk, Russia Technion, Israel Institute of Technology University of Latvia Vanderbilt University Vitebsk Medical University, Belarus