Clinical trial NCT06301464: Pepsinogen II and Helicobacter Pylori Test in Gastric Cancer
Official title: Validation of Serum Pepsinogen II and Helicobacter Pylori Test in the Detection of Gastric Cancer in South Korea
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gastric Cancer
Keywords: Gastric cancer
Pepsinogen
Helicobacter pylori
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 24000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: The level of serum pepsinogens
timeFrame: At the time of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Nayoung Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: