Validation of Serum Pepsinogen II and Helicobacter Pylori Test in the Detection of Gastric Cancer in South Korea
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24,000
- 试验地点
- 1
- 主要终点
- The level of serum pepsinogens
研究概览
简要总结
The aim of this study to validate the role of pepsinogens in gastric cancer screening.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
The level of serum pepsinogens
时间窗: At the time of enrollment
To compare the level of serum pepsinogens between the two groups
次要结局
未报告次要终点
研究者
Nayoung Kim
Professor
Seoul National University Bundang Hospital