Validation of Serum Assays for the Diagnosis of Gastritis

Cancer Screening Tests Clinical Trial

Official title:

Validation of Serum Assays for the Diagnosis of Gastritis in Adult Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05883345
• Other study ID #: 2023-04-056
• Status: Recruiting
• Start date: April 24, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: Konkuk University Medical Center
• Contact: Sun-Young Lee, MD, PhD
• Phone: 82-2-2030-7505
• Email: sunyoung1973.lee[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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. Furthermore, the efficacy of blood tests in discriminating type A (reverse atrophy), type B (atrophy), and non-atrophic gastritis will be analyzed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: December 31, 2025
• Est. primary completion date: April 23, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Individuals who visited for gastric cancer screening

Exclusion Criteria:

• History of gastrectomy

• Renal insufficiency

• Severe comorbidities requiring prompt management

Related Conditions & MeSH terms

• Cancer Screening Tests
• Gastritis

Intervention

Diagnostic Test:
• Serum blood test for Helicobacter pylori immunoglobulin G, pepsinogen, and gastrin levels
Endoscopic biopsy

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity of blood tests for gastric cancer screening and gastritis type	Type A (reverse atrophy), type B (atrophy), and non-atrophic gastritis	up to two years