Gastric CancerNCT06301464
Pepsinogen II and Helicobacter Pylori Test in Gastric Cancer
An observational study of Gastric Cancer, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The aim of this study to validate the role of pepsinogens in gastric cancer screening. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- How many people
- 24,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2003to 31 Dec 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects who have undergone a blood test for serum pepsinogens and anti-H. pylori antibody, have undergone an esophagogastroduodenoscopy test three months before and after the blood test, have no other reason for exclusion, and have agreed to participate in the study
Who may be able to join
- Who undergoes serum pepsinogens and anti-H. pylori antibody tests, and esophagogastroduodenoscopy during a health-screening examination at Seoul National University Hospital Gangnam center (SNUHGC) or Seoul National University Bundang Hospital (SNUBH)
Who cannot join
- Who do not receive serum pepsinogens or anti-H. pylori antibody studies
- Who do not receive esophagogastroduodenoscopy within 3 months before or after the date of serum pepsinogens and anti-H. pylori antibody tests
- Subjects with recent proton-pump inhibitor therapy 1 month prior to enrollment
- Subjects with prior history of gastrectomy
- Subjects with upper gastrointestinal neoplasms other than gastric adenoma/adenocarcinoma
- Subjects who do not agree to participate in the study or withdraw his/her consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Validation of Serum Pepsinogen II and Helicobacter Pylori Test in the Detection of Gastric Cancer in South Korea
The aim of this study to validate the role of pepsinogens in gastric cancer screening.
Read the detailed description
Serum pepsinogens (PGs) are the biomarkers for gastric cancer (GC), especially atrophic gastritis which is a precursor of intestinal type GC and severe gastric inflammation which is an indicator for diffuse type GC in young age. So, test for serum PGs can be used to identify high risk patients for GC. The aim of this study is to validate the role of PGs in GC screening.
Sera and the data from esophagogastroduodenoscopy and questionnaires are collected from study subjects, and PGs and anti-H. pylori (HP) antibody are measured. Area under the curve and receiver operating characteristic curve are calculated to identify the optimal cutoff values for PGs.
To validate the usefulness of PGs to predict risk of GC, the subjects are divided into two groups based on each cut-off value for each PG value. Adjusted odds ratios (ORs) and 95% CIs are calculated using multivariate logistic regression. Risk stratification is conducted by combining each PG value and anti-HP antibody in GC subtype.
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, Pepsinogen, Helicobacter pylori
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with gastric neoplasms | Patients with gastric neoplasms | |
| Normal control | Normal control without gastric neoplasms |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of serum pepsinogens
To compare the level of serum pepsinogens between the two groups
Measured: At the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Mar 2003
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 24,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayoung Kim, Seoul National University Bundang Hospital
- Investigators
- Nayoung Kim, M.D., Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301464
- Sponsor's protocol ID
- B-2003-603-103
- Status last verified
- Nov 2024
- First submitted
- 2 Mar 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Serum Pepsinogen II and Helicobacter Pylori Test in the Detection of Gastric Cancer in South Korea
- ClinicalTrials.gov ID
- NCT06301464
- Acronym / sponsor ID
- B-2003-603-103
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, Pepsinogen, Helicobacter pylori
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 24,000 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Mar 2003 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study to validate the role of pepsinogens in gastric cancer screening.
Detailed description
Serum pepsinogens (PGs) are the biomarkers for gastric cancer (GC), especially atrophic gastritis which is a precursor of intestinal type GC and severe gastric inflammation which is an indicator for diffuse type GC in young age. So, test for serum PGs can be used to identify high risk patients for GC. The aim of this study is to validate the role of PGs in GC screening.
Sera and the data from esophagogastroduodenoscopy and questionnaires are collected from study subjects, and PGs and anti-H. pylori (HP) antibody are measured. Area under the curve and receiver operating characteristic curve are calculated to identify the optimal cutoff values for PGs.
To validate the usefulness of PGs to predict risk of GC, the subjects are divided into two groups based on each cut-off value for each PG value. Adjusted odds ratios (ORs) and 95% CIs are calculated using multivariate logistic regression. Risk stratification is conducted by combining each PG value and anti-HP antibody in GC subtype.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with gastric neoplasms | – | –Patients with gastric neoplasms |
| Normal control | – | –Normal control without gastric neoplasms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have undergone a blood test for serum pepsinogens and anti-H. pylori antibody, have undergone an esophagogastroduodenoscopy test three months before and after the blood test, have no other reason for exclusion, and have agreed to participate in the study
Key inclusion criteria (1 listed)
- Who undergoes serum pepsinogens and anti-H. pylori antibody tests, and esophagogastroduodenoscopy during a health-screening examination at Seoul National University Hospital Gangnam center (SNUHGC) or Seoul National University Bundang Hospital (SNUBH)
Key exclusion criteria (6 listed)
- Who do not receive serum pepsinogens or anti-H. pylori antibody studies
- Who do not receive esophagogastroduodenoscopy within 3 months before or after the date of serum pepsinogens and anti-H. pylori antibody tests
- Subjects with recent proton-pump inhibitor therapy 1 month prior to enrollment
- Subjects with prior history of gastrectomy
- Subjects with upper gastrointestinal neoplasms other than gastric adenoma/adenocarcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The level of serum pepsinogens
Time frame: At the time of enrollment
To compare the level of serum pepsinogens between the two groups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- 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.
Nayoung Kim, M.D., Ph.D. principal investigator
Seoul National University Bundang Hospital
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 Gastric Cancer, run by Seoul National University Bundang Hospital 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 6 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: under way, not looking for participants, as of the sponsor's last update on 29 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
The level of serum pepsinogens (time frame: At the time of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2024.