Blood Tests for Gastritis and Gastric Neoplasms

NCT05883345 | Completed Results

• 1 other identifier: 2023-04-056
• Study Type: observational
• Target: 1,490
• Locations: 1 country
• Sites: 1

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).

Conditions

Cancer Screening Tests

Keywords

Helicobacter pylori; Atrophic gastritis; Gastric cancer; Pepsinogen

Outcome Measures

Primary Outcomes (1)

• Significant Blood Test Findings Correlated With Gastric Neoplasms

  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.)

  15 months

Secondary Outcomes (1)

• Test Findings Correlated With the Presence of Gastric Neoplasms

  15 months

Interventions

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

Endoscopic biopsy

Also known as: Upper gastrointestinal endoscopy, Urea breath test

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult population who visited our center for gastric cancer screening using serum assays

You may qualify if:

• Individuals who visited for gastric cancer screening

You may not qualify if:

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

Sponsors & Collaborators

• Konkuk University Medical Center: lead

Study Sites (1)

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Related Publications (1)

• 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.

  PMID: 40211909 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

Gastritis, Atrophic; Stomach Neoplasms

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Gastritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Sun-Young Lee
• Organization: Konkuk University Medical Center

sunyoung1973.lee@gmail.com

82-2-2030-7747

Study Officials

• Sun-Young Lee, MD, PhD

  Department of Internal Medicine, Konkuk University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 31, 2023
• Study Start: May 1, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: March 11, 2025
• Results First Posted: March 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)