Helicobacter Pylori Eradication to Prevent Gastric Cancer in a High-Risk Population of China: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Gastric cancer incidence
研究概览
简要总结
Gastric cancer is the fourth most common type of cancer and the second leading cause of cancer-related death in the world. In China, more than 390,000 new patients are diagnosed with gastric cancer and more than 300,000 patients are killed by the terrible disease annually. Although gastric cancer has a multifactorial etiology, infection with H. pylori is highly associated with gastric carcinogenesis. Therefore, eradication of H. pylori infection appears to reduce the risk of gastric cancer. However, several recent controlled interventional trials by H. pylori eradication to prevent gastric cancer have yielded disappointing results. The exact effect of H.pylori eradication on prevention of gastric cancer is unclear up to now. To clarify this problem, the investigators conducted a prospective, randomized, double-blind, placebo-controlled, population-based study to determine whether H pylori eradication would reduce the incidence of gastric cancer in a high-risk population in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy registered inhabitants from 10 villages in a high-risk county of gastric cancer in China
- •Age 30-59 years
- •A willingness to participate in the study as indicated by written informed consent
排除标准
- •Severe concomitant illness (eg, severe hypertension, coronary heart disease, diabetes mellitus, stroke, asthma, liver cirrhosis, tuberculosis, infectious hepatitis, and cardiac, respiratory, hepatic, or renal insufficiency)
- •Patients with epilepsy or severe mental illness
- •Previous diagnosis of cancer
- •A history of esophageal or gastric surgery
- •Drug abuse and drug dependence
- •Allergic to omeprazole, amoxicillin, or clarithromycin
- •Pregnant and lactating women
- •Previous history of H pylori eradication treatment
- •A negative 13C-urea breath test (UBT)
- •A definite indication of H. pylori eradication (eg, gastric or duodenum ulcer)
- •Dysplasia or carcinoma lesions are found in esophageal or gastric histopathological examination
- •Other factors or conditions might influence the results of study
研究组 & 干预措施
OAC triple therapy
干预措施: OAC triple therapy (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Gastric cancer incidence
时间窗: 10 years
The incidence of gastric cancer in the two groups
次要结局
- Histopathological changes(10 years)
研究者
Jie-Jun Wang
MD
Second Military Medical University