Cancer Screening Tests
Conditions
Keywords
Helicobacter pylori, Atrophic gastritis, Gastric cancer, Pepsinogen
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.
Interventions
DIAGNOSTIC_TESTSerum blood test for Helicobacter pylori immunoglobulin G, pepsinogen, and gastrin-17 levels
Endoscopic biopsy
Sponsors
Konkuk University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Individuals who visited for gastric cancer screening
Exclusion criteria
* History of gastrectomy * Renal insufficiency * Severe comorbidities requiring prompt management
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Significant Blood Test Findings Correlated With Gastric Neoplasms | 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
| Measure | Time frame | Description |
|---|---|---|
| Test Findings Correlated With the Presence of Gastric Neoplasms | 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 |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Gastric Neoplasm Individuals without gastric neoplasms | 979 |
| Gastric Neoplasm Individuals with gastric neoplasms | 122 |
| Total | 1,101 |
Baseline characteristics
| Characteristic | No Gastric Neoplasm | Gastric Neoplasm | Total |
|---|---|---|---|
| Age, Continuous | 51.3 years STANDARD_DEVIATION 15.5 | 66.8 years STANDARD_DEVIATION 10.1 | 53.0 years STANDARD_DEVIATION 15.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 979 Participants | 122 Participants | 1101 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 451 Participants | 42 Participants | 493 Participants |
| Sex: Female, Male Male | 528 Participants | 80 Participants | 608 Participants |
| Status of H. pylori infection Current | 355 Number of individuals | 88 Number of individuals | 443 Number of individuals |
| Status of H. pylori infection Naive | 321 Number of individuals | 2 Number of individuals | 323 Number of individuals |
| Status of H. pylori infection Past | 303 Number of individuals | 32 Number of individuals | 334 Number of individuals |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 979 | 0 / 122 |
| other Total, other adverse events | 21 / 979 | 4 / 122 |
| serious Total, serious adverse events | 0 / 979 | 0 / 122 |
Outcome results
Primary
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.)
Time frame: 15 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Gastric Neoplasm | Significant Blood Test Findings Correlated With Gastric Neoplasms | 9.9 score on a scale | Standard Deviation 3.9 |
| Gastric Neoplasm | Significant Blood Test Findings Correlated With Gastric Neoplasms | 6.5 score on a scale | Standard Deviation 3.2 |
Secondary
Test Findings Correlated With the Presence of Gastric Neoplasms
Gastrin-17 levels measured by the GastroPanel tests on the day of other serologic tests including pepsinogen levels and Helicobacter pylori IgG titers
Time frame: 15 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| No Gastric Neoplasm | Test Findings Correlated With the Presence of Gastric Neoplasms | 2.9 pmol/L |
| Gastric Neoplasm | Test Findings Correlated With the Presence of Gastric Neoplasms | 11.8 pmol/L |