Blood Tests for Gastritis and Gastric Neoplasms

NCT ID: NCT05883345

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1490 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-08-30

Brief Summary

Helicobacter pylori infection rate is decreasing in younger population; however, biennial gastroscopy is still recommended for all Koreans aged between 40 and 75 years. This study aimed to validate blood tests for gastric cancer screening according to the infection status of H. pylori (naive, current, and past infection).

Detailed Description

Helicobacter pylori-seropositive rates are decreasing in South Korea. Seroprevalence was 74.3% in 1990, but it decreased to 43.9% in 2016. In Koreans, most gastric cancers are related to H. pylori infection. H. pylori-negative gastric cancers were found only in 2.3% among the 1,833 Korean gastric cancer patients. Despite these facts, the national guideline still recommends biennial gastroscopy for all Koreans aged between 40 and 75 years. Therefore, 8,462,570 (63.1%) Koreans underwent gastric cancer screening among the target population of 13,404,927 individuals in 2021.

In H. pylori-seroprevalent populations, diagnostic criteria for naive status should be strict based on histology, endoscopy, and serum pepsinogen (PG) assay findings. Naive condition should be diagnosed only when both invasive and non-invasive H. pylori tests show negative findings. Furthermore, there should be no intestinal metaplasia and atrophy on serum PG assay, endoscopy, and histology findings in H. pylori-naive participants. Based on those findings, H. pylori infection will be confirmed when invasive tests or urea breath test was positive. H. pylori-naive status will be diagnosed if there was no eradication history, no serologically detected atrophy (PG I ≤70 ng/mL and PG I/II ≤3), and no intestinal metaplasia or atrophy on endoscopy and histology.

This study aimed to determine the validity of blood tests for gastric cancer screening according to the H. pylori infection status. We tried to identify significant variables using GastroPanel tests and traditional serum PG assays in patients with gastric neoplasms.

Conditions

Cancer Screening Tests

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Serum blood test for Helicobacter pylori immunoglobulin G, pepsinogen, and gastrin-17 levels

Endoscopic biopsy

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Upper gastrointestinal endoscopy; Urea breath test

Eligibility Criteria

Inclusion Criteria

• Individuals who visited for gastric cancer screening

Exclusion Criteria

• History of gastrectomy
• Renal insufficiency
• Severe comorbidities requiring prompt management

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Konkuk University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sun-Young Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Konkuk University School of Medicine

Locations

Konkuk University Medical Center

Seoul, , South Korea

Countries

South Korea

References

Lee SY, Moon HW, Ahn YS, Song JH, Kim JH, Sung IK. A Prospective Study on the Detection of Gastric Neoplasms Using Pepsinogen and Gastrin-17 Levels. Gut Liver. 2025 Jul 15;19(4):548-558. doi: 10.5009/gnl240544. Epub 2025 Apr 11.

Reference Type: DERIVED

PMID: 40211909 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2023-04-056

Identifier Type: -

Identifier Source: org_study_id