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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).
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serum blood test for Helicobacter pylori immunoglobulin G, pepsinogen, and gastrin-17 levels | Diagnostic Test | Endoscopic biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 15 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult population who visited our center for gastric cancer screening using serum assays
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| Name | Affiliation | Role |
|---|---|---|
| Sun-Young Lee, MD, PhD | Department of Internal Medicine, Konkuk University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konkuk University Medical Center | Seoul | 05030 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40211909 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | No Gastric Neoplasm Group | Individuals without gastric neoplasms |
| FG001 | Gastric Neoplasm Group | Individuals with gastric neoplasms |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Gastric Neoplasm | Individuals without gastric neoplasms |
| BG001 | Gastric Neoplasm | Individuals with gastric neoplasms |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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.) | Posted | Mean | Standard Deviation | score on a scale | 15 months |
|
|
Adverse events were recorded on the day of examination and on the day of follow-up visit at the outpatient clinic. Time Frame 1: On the day of upper gastrointestinal endoscopy and blood tests Time Frame 2: Up to 6 months
Adverse events were defined as symptoms that disturbed daily activities by requiring management to subside the symptoms. Adverse events include perforation, bleeding, infection, cardiopulmonary events, etc.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Gastric Neoplasm Group | Individuals without gastric neoplasms | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Perforation, bleeding, infection, etc. | Gastrointestinal disorders | Systematic Assessment | Gastrointestinal perforation, bleeding, and infection which required treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoxemia | Injury, poisoning and procedural complications | Systematic Assessment | SpO2 was monitored using a pulse oximetry for upper gastrointestinal endoscopy. Only mild hypoxemia (which did not require further management) was noticed during the study period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sun-Young Lee | Konkuk University Medical Center | 82-2-2030-7747 | 7505 | sunyoung1973.lee@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 28, 2023 | Oct 20, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005757 | Gastritis, Atrophic |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005756 | Gastritis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D016145 | Endoscopy, Digestive System |
| ID | Term |
|---|---|
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
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Blood sample
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Status of H. pylori infection | Number | Number of individuals |
|
| Counts |
|---|
| Participants |
|
|
| 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 | Posted | Median | Full Range | pmol/L | 15 months |
|
|
|
| 979 |
| 0 |
| 979 |
| 21 |
| 979 |
| EG001 | Gastric Neoplasm Group | Individuals with gastric neoplasms | 0 | 122 | 0 | 122 | 4 | 122 |
|
|
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| D013272 |
| Stomach Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |