Randomized Multicenter Study to Prevent Gastric Cancer Deaths Using H. Pylori Eradication and Pepsinogen Testing in Adults Aged 40 to 64

What this Trial Is About

This research aims to evaluate if screening for Helicobacter pylori H. pylori infection followed by treatment for those who test positive and endoscopic monitoring of individuals with signs of atrophic gastritis can reduce deaths from gastric cancer in middle-aged adults living in high-risk regions. The study is a large, multicenter randomized trial involving 30,000 participants aged 40 to 64 years from areas with high gastric cancer rates in Latvia, Belarus, and Russia. The goal is to determine the impact of these strategies on gastric cancer mortality over 15 years of follow-up. Participants will be randomly assigned to one of two groups. The first group will receive H. pylori screening through blood tests and pepsinogen testing, with those testing positive offered a 10-day triple therapy to eradicate H. pylori and those with atrophic gastritis undergoing endoscopy with biopsies and follow-up as needed. Breath samples will also be collected from this group for additional biomarker studies. The second group will receive usual care without intervention but will be offered fecal occult blood testing FOBT to detect other gastrointestinal issues. Positive FOBT results in both groups will lead to colonoscopy referrals. Throughout the study, participants will complete questionnaires and receive medical evaluations at enrollment. Follow-up will occur for at least 15 years, including telephone or other communications every 5 years to assess health outcomes, particularly gastric cancer incidence and mortality. Researchers will monitor differences in cancer rates and deaths between the groups, study biomarkers for atrophic gastritis, assess volatile markers in breath, and evaluate the effects of eradication on other health conditions. This long-term monitoring aims to identify effective prevention methods for gastric cancer in high-risk populations.

Multicentric Randomized Study of H. Pylori Eradication and Pepsinogen Testing for Prevention of Gastric Cancer Mortality