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Trial Title:
Validation of Serum Assays for the Diagnosis of Gastritis
NCT ID:
NCT05883345
Condition:
Cancer Screening Tests
Conditions: Official terms:
Gastritis
Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
Immunoglobulin G
Gastrins
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Serum blood test for Helicobacter pylori immunoglobulin G, pepsinogen, and gastrin levels
Description:
Endoscopic biopsy
Other name:
Upper gastrointestinal endoscopy
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. Furthermore, the efficacy of blood tests in
discriminating type A (reverse atrophy), type B (atrophy), and non-atrophic gastritis
will be analyzed.
Criteria for eligibility:
Study pop:
Adult population who visited our center for gastric cancer screening using serum assays
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Individuals who visited for gastric cancer screening
Exclusion Criteria:
- History of gastrectomy
- Renal insufficiency
- Severe comorbidities requiring prompt management
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Konkuk University Medical Center
Address:
City:
Seoul
Zip:
05030
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Sun-Young Lee, MD, PhD
Phone:
82-2-2030-7505
Email:
sunyoung1973.lee@gmail.com
Start date:
April 24, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Konkuk University Medical Center
Agency class:
Other
Source:
Konkuk University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05883345
