Cancer Screening TestsNCT05883345
Blood Tests for Gastritis and Gastric Neoplasms
An observational study of Cancer Screening Tests, run by Konkuk University Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cancer Screening Tests
- What is being tested?
- Serum blood test for Helicobacter pylori immunoglobulin G, pepsinogen, and gastrin-17 levels
- How many people
- 1,490 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2023to 30 Aug 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult population who visited our center for gastric cancer screening using serum assays
Who may be able to join
- Individuals who visited for gastric cancer screening
Who cannot join
- History of gastrectomy
- Renal insufficiency
- Severe comorbidities requiring prompt management
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Blood Test Finding for the Diagnosis of Gastritis and Gastric Neoplasms
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).
Read the 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.
- Conditions
- Cancer Screening Tests
- Being tested
- Serum blood test for Helicobacter pylori immunoglobulin G, pepsinogen, and gastrin-17 levels
- Keywords
- Helicobacter pylori, Atrophic gastritis, Gastric cancer, Pepsinogen
- Medical subject headings
- Gastritis, Atrophic, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum blood test for Helicobacter pylori immunoglobulin G, pepsinogen, and gastrin-17 levelsDiagnostic test
Also called Upper gastrointestinal endoscopy, Urea breath test
Endoscopic biopsy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 15 months
Secondary outcomes (1)
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
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 May 2023
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer Screening TestsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,490 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sun-Young Lee, MD, PhD, Principal investigator, Department of Internal Medicine, Konkuk University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883345
- Sponsor's protocol ID
- 2023-04-056
- Status last verified
- Jan 2025
- First submitted
- 9 May 2023
- Last updated
- 11 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40211909
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Blood Test Finding for the Diagnosis of Gastritis and Gastric Neoplasms
- ClinicalTrials.gov ID
- NCT05883345
- Acronym / sponsor ID
- 2023-04-056
- Conditions
- Cancer Screening Tests
- Keywords
- Helicobacter pylori, Atrophic gastritis, Gastric cancer, Pepsinogen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,490 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 31 May 2023 (actual)
- Results
- Posted 11 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult population who visited our center for gastric cancer screening using serum assays
Key inclusion criteria (1 listed)
- Individuals who visited for gastric cancer screening
Key exclusion criteria (3 listed)
- History of gastrectomy
- Renal insufficiency
- Severe comorbidities requiring prompt management
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum blood test for Helicobacter pylori immunoglobulin G, pepsinogen, and gastrin-17 levelsAlso: Upper gastrointestinal endoscopy, Urea breath testEndoscopic biopsy | Diagnostic test | – |
Primary outcome
Significant Blood Test Findings Correlated With Gastric Neoplasms
Time frame: 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.)
1 secondary outcome
Test Findings Correlated With the Presence of Gastric Neoplasms
Time frame: 15 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40211909Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sun-Young Lee, MD, PhD principal investigator
Department of Internal Medicine, Konkuk University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Screening Tests, run by Konkuk University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant Blood Test Findings Correlated With Gastric Neoplasms (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05883345, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.