Pepsinogen II and Helicobacter Pylori Test in Gastric Cancer

Seoul National University

Status: Active, not recruiting

Conditions: Gastric Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06301464

B-2003-603-103

Details and patient eligibility

About

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

Full 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.

Enrollment: 24,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

24,000 participants in 2 patient groups

Patients with gastric neoplasms

Description:

Patients with gastric neoplasms

Normal control

Description:

Normal control without gastric neoplasms