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Completed

NCT Number: NCT05883345

Blood Tests for Gastritis and Gastric Neoplasms

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).

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Konkuk University Medical Center

Seoul, 05030, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals who visited for gastric cancer screening

Exclusion criteria

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

Treatment and study plan

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

Diagnostic Test

Endoscopic biopsy

Other names: Upper gastrointestinal endoscopy, Urea breath test

Primary outcomes

  1. Significant Blood Test Findings Correlated With Gastric Neoplasms

    Time frame: 15 months

    Serum pepsinogen I/II ratios indicating the presence gastric neoplasms (Minimum and maximum ratios were 0.2 and 19.1, respectively. Lower ratios indicate worse outcome.)

Secondary outcomes

  1. Test Findings Correlated With the Presence of Gastric Neoplasms

    Time frame: 15 months

    Gastrin-17 levels measured by the GastroPanel tests on the day of other serologic tests including pepsinogen levels and Helicobacter pylori IgG titers

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Official study title

Validation of Blood Test Finding for the Diagnosis of Gastritis and Gastric Neoplasms

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 31, 2023
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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