Pepsinogen II and Helicobacter Pylori Test in Gastric Cancer

N/AActive Not RecruitingNCT06301464

Seoul National University Bundang Hospital24,000 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

24,000

Conditions

Gastric Cancer

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Who undergoes serum pepsinogens and anti-H. pylori antibody tests, and esophagogastroduodenoscopy during a health-screening examination at Seoul National University Hospital Gangnam center (SNUHGC) or Seoul National University Bundang Hospital (SNUBH) Exclusion Criteria: * Who do not receive serum pepsinogens or anti-H. pylori antibody studies * Who do not receive esophagogastroduodenoscopy within 3 months before or after the date of serum pepsinogens and anti-H. pylori antibody tests * Subjects with recent proton-pump inhibitor therapy 1 month prior to enrollment * Subjects with prior history of gastrectomy * Subjects with upper gastrointestinal neoplasms other than gastric adenoma/adenocarcinoma * Subjects who do not agree to participate in the study or withdraw his/her consent

Locations (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

The level of serum pepsinogens

To compare the level of serum pepsinogens between the two groups

Time frame: At the time of enrollment

Data from ClinicalTrials.gov

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