Risk of Gastric Cancer in High-risk Carriers of Helicobacter Pylori: an Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Difference in incidence of gastric cancer between the three groups (HP positive high-risk, HP positive non-high-risk, and HP negative) during a 3-year follow-up.
研究概览
简要总结
This study is intended to be a prospective observational cohort study. The incidence of gastric cancer and progression of gastric precancerous lesions will be compared between groups through prospective follow-up of a population with baseline negative gastric endoscopy, harboring high-risk Hp SNP subtypes and non-high-risk subtypes.
详细描述
Primary study objective: to assess the difference in the incidence of gastric cancer between carriers of high-risk SNP subtypes of H. pylori and the non-high-risk population during the follow-up period.
Secondary research objectives: 1. To observe and compare the cumulative incidence and progression of gastric precancerous lesions (e.g., atrophic gastritis, intestinal metaplasia, etc.) in each population group during the follow-up period.2. To explore the interaction of high-risk SNPs on the risk of gastric cancer in the context of different age, gender or other risk factors (e.g. diet, smoking, alcohol abuse, family history, etc.).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 40 years, gender is not limited.
- •Able and willing to provide informed consent and willing to undergo baseline and follow-up examinations.
排除标准
- •A history of diagnosed gastric cancer or other malignant tumors of the digestive tract.
- •Comorbid severe underlying conditions (e.g., severe cardiopulmonary insufficiency, liver or renal failure, etc.) that are likely to result in a short life expectancy or render long-term follow-up impractical.
- •Severe mental illness or incapacity to participate in the study due to lack of civil behavior.
- •Pregnant or breastfeeding women.
- •Other conditions that the investigator deems inappropriate for participation in the study.
研究组 & 干预措施
exposure group
HP positive with high-risk SNP subtypes
干预措施: observational study (Other)
Control 1
Hp positive + non-high risk SNP
干预措施: observational study (Other)
Control 2
Hp negative
干预措施: observational study (Other)
结局指标
主要结局
Difference in incidence of gastric cancer between the three groups (HP positive high-risk, HP positive non-high-risk, and HP negative) during a 3-year follow-up.
时间窗: From enrollment to the end of the study in 3 years
Evaluate the difference in the incidence of gastric cancer between high-risk and non-high-risk groups, while considering the comparison with the HP negative group. The comparison between the three groups (HP positive high-risk, HP positive non-high-risk, and HP negative) will assess the difference in gastric cancer incidence during a 3-year follow-up. Gastric cancer incidence will be determined based on pathological confirmation (biopsy results).
次要结局
- Difference in incidence of gastric cancer between the three groups (HP positive high-risk, HP positive non-high-risk, and HP negative) at 5-, and 10-year follow-up time points.(From enrollment to the end of the study in 10 years)
- Differences in the incidence of gastric precancerous lesions among three groups (Hp-positive high-risk, Hp-positive non-high-risk, and Hp-negative) at 3-, 5-, and 10-year follow-up time points.(From enrollment to the end of the study in 10 years)