Endoscopy trial (PYLOTUM)

Within the research presence funded by the German Ministry for Education and Research (BMBF) PYLOTUM, we are conducting an endoscopic screening study, enrolling 10 000 volunteer residents from Linqu County. All participants will be endoscopically followed up every 3 years for up to 10 years, and gastric pathology will be assessed using a standardized biopsy mapping protocol. The goal of this study is to determine the molecular and histopathological features of the gastric mucosa with and without H. pylori therapy under endoscopic surveillance. Molecular sub-studies will be performed to prospectively assess the individual risk for gastric cancer and for certain pre-neoplastic lesions by blood and tissue markers. Based on this, a risk score (also including other risk factors like age, gender, and smoking) will be established. This study is an important next step after the ongoing “Large-Linqu-Trial”, addressing histopathologic, serologic and molecular biomarkers for assessment of gastric cancer risk. Since health resources and antibiotic resistance currently do not allow a mass antibiotic treatment, it is of high clinical and economic impact to identify those individuals that are at high risk and would profit from preventive eradication and require endoscopic surveillance. If the study should confirm the assumed preventive effect of H. pylori treatment on development or progression of gastric precancerous lesions, anti-microbial treatment should be made available for the H. pylori positive persons who are at particular risk of developing gastric cancer, not only in Linqu County. The identification of biomarkers is an important aspect to improve early detection, especially in countries where prevalence is high and gastroscopic screening is not readily available for the broad population.