NCT06301464

Pepsinogen II and Helicobacter Pylori Test in Gastric Cancer

Validation of Serum Pepsinogen II and Helicobacter Pylori Test in the Detection of Gastric Cancer in South Korea

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 24,000 (estimated)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The aim of this study to validate the role of pepsinogens in gastric cancer screening.

Detailed description

Serum pepsinogens (PGs) are the biomarkers for gastric cancer (GC), especially atrophic gastritis which is a precursor of intestinal type GC and severe gastric inflammation which is an indicator for diffuse type GC in young age. So, test for serum PGs can be used to identify high risk patients for GC. The aim of this study is to validate the role of PGs in GC screening. Sera and the data from esophagogastroduodenoscopy and questionnaires are collected from study subjects, and PGs and anti-H. pylori (HP) antibody are measured. Area under the curve and receiver operating characteristic curve are calculated to identify the optimal cutoff values for PGs. To validate the usefulness of PGs to predict risk of GC, the subjects are divided into two groups based on each cut-off value for each PG value. Adjusted odds ratios (ORs) and 95% CIs are calculated using multivariate logistic regression. Risk stratification is conducted by combining each PG value and anti-HP antibody in GC subtype.

Conditions

• Gastric Cancer

Timeline

• Start date: 2003-03-01
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2024-03-08
• Last updated: 2024-11-29

Locations

1 site across 1 country: South Korea