Pepsinogen II and Helicobacter Pylori Test in Gastric Cancer
NCT ID: NCT06301464
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
24000 participants
OBSERVATIONAL
2003-03-01
2025-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Patients with gastric neoplasms
Patients with gastric neoplasms
No interventions assigned to this group
Normal control
Normal control without gastric neoplasms
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Seoul National University Bundang Hospital
OTHER
Responsible Party
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Nayoung Kim
Professor
Principal Investigators
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Nayoung Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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B-2003-603-103
Identifier Type: -
Identifier Source: org_study_id