Effect of Helicobacter Pylori Eradication on Gastric Cancer Prevention in Korea: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 5,224
- 试验地点
- 11
- 主要终点
- The incidence of gastric cancer between the intervention and placebo groups
研究概览
简要总结
The aim of this study is to define the role of H. pylori eradication in the prevention of gastric cancer and its precursors in the context of a population-based endoscopic screening program.
详细描述
Despite the decreasing incidence observed in the US and West European countries, gastric cancer is still an important global public health problem, especially in East Asian countries, where the burden of the disease is substantial. In the Republic of Korea, gastric cancer remains the leading cause of cancer in men and the fourth most common cancer in women. There is sufficient epidemiological and experimental evidence supporting a causal link between bacterial infection with H. pylori and gastric cancer development. However, evidence from clinical trials on the efficacy of H. pylori eradication with antimicrobial therapy to reduce the risk of gastric cancer is still limited. In addition, the beneficial or deleterious health impact of mass eradication at the population level has not been defined. In Korea, the prevalence of H. pylori infection in adults is still relatively high (~60%, >16 years old), and despite important reductions in mortality attributed to the screening program, incidence of gastric cancer remains elevated.
The investigators propose to conduct a randomized controlled clinical trial in Korea to evaluate the efficacy of H. pylori eradication to prevent gastric cancer incidence in different population subgroups including age and baseline gastric pathology. This study will be conducted in the context of the National Cancer Screening Program and the Korean Central Cancer Registry.
The proposed study will be a collaborative investigation between the National Cancer Center, Korea and the International Agency for Research on Cancer of the World Health Organization.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 40-65 who are invited to participate in the National Cancer Screening Program and receive upper endoscopy
- •Willingness to sign an informed consent form
- •Good health, as determined by medical history and physical examination at enrollment
排除标准
- •Personal history of gastric cancer
- •Family history of gastric cancer in a first degree relative
- •Diagnosis and active treatment for other organ cancer except carcinoma in situ within 5 years
- •Current treatment for serious medical condition which could hinder participation (such as liver cirrhosis, renal failure, pulmonary dysfunction including COPD or asthma, or uncontrolled infection)
- •Inadequate cardiovascular function including (a) New York Heart Association class III or IV heart disease, (b) unstable angina or myocardial infarction history, (c) history of significant ventricular arrhythmia requiring medication with antiarrhythmics, and (d) history of cerebrovascular accident
- •Requirement for therapeutic anticoagulant therapy, aspirin
- •Gastric resections due to benign disease
- •H. pylori eradication therapy history
- •Mental incompetence to understand and sign informed consent
- •Alcoholism, drug abuse
- •Serious chronic diseases according to the evaluation of the study physician
- •Presence of a contraindication to the use of eradication treatment regimens
- •Inability to provide an informed consent
- •Pregnant or lactating women
- •Treatment required due to peptic ulcer, gastric cancer or esophageal cancer identified during the endoscopic examination
研究组 & 干预措施
Intervention group
10-day bismuth-based quadruple therapy for H. pylori positive subjects
干预措施: 10-day bismuth-based quadruple therapy (Drug)
Placebo group
Placebo for H. pylori positive subjects
干预措施: Placebo (Other)
结局指标
主要结局
The incidence of gastric cancer between the intervention and placebo groups
时间窗: Up to 10 years After H. pylori eradication
Histologically confirmed gastric adenocarcinoma stage 1A or more advanced defined at endoscopy or through cancer registry
次要结局
- Modification of atrophy score(Up to 10 years After H. pylori eradication)
- Occurrence of adverse events caused by antibiotic treatment(During 10 days of H. pylori eradication, and Up To 1 month after the treatment completion)
- Incidence and mortality from other medical conditions such as obesity, diabetes, circulatory diseases, oesophageal diseases as well as other cancers and cognitive impairment(Up to 10 years After H. pylori eradication)
- All-cause mortality(Up to 10 years After H. pylori eradication)
- Incidence of gastric dysplasia(Up to 10 years After H. pylori eradication)
- Mortality from gastric cancer(Up to 10 years after eradication)
研究者
Il Ju Choi
Head of Gastric Cancer Cencer
National Cancer Center, Korea