Clinical trial NCT05883345: Blood Tests for Gastritis and Gastric Neoplasms
Official title: Validation of Blood Test Finding for the Diagnosis of Gastritis and Gastric Neoplasms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Screening Tests
Keywords: Helicobacter pylori
Atrophic gastritis
Gastric cancer
Pepsinogen
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 1490
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult population who visited our center for gastric cancer screening using serum assays

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.

Eligibility criteria: Inclusion Criteria:

* Individuals who visited for gastric cancer screening

Exclusion Criteria:

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

Primary outcomes:
measure: Significant Blood Test Findings Correlated With Gastric Neoplasms
timeFrame: 15 months
Secondary outcomes:
measure: Test Findings Correlated With the Presence of Gastric Neoplasms
timeFrame: 15 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Department of Internal Medicine, Konkuk University School of Medicine
name: Sun-Young Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: