Helicobacter Pylori Eradication to Prevent Gastric Cancer in Subjects With Family History of Gastric Cancer: A Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,838
- 试验地点
- 1
- 主要终点
- Gastric cancer incidence
研究概览
简要总结
This study evaluate whether treatment of Helicobacter pylori infection reduces the incidence of gastric cancer in subjects with family history of gastric cancer.
详细描述
Helicobacter pylori infection is associated with gastric cancer in epidemiological studies. However, it is still unknown whether H. pylori eradication is useful and required to prevent gastric cancer.
Gastric cancer risk is increased in family members of gastric cancer patient. Though there is no direct evidence that H. pylori infection is a risk factor for gastric cancer in family members of gastric cancer, current European guideline recommends H. pylori eradication in first-degree relatives of gastric cancer patients.
In this study, the investigators will evaluate whether H. pylori eradication can reduce gastric cancer risk in the first-degree family members of gastric cancer patients.
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
- •Sibling or offspring of patients with gastric adenocarcinoma confirmed by EGD and biopsy
- •Informed consent should be signed
排除标准
- •Gastric cancer history
- •Other malignancy within the past 5 years
- •Hereditary cancer family member (HNPCC, FAP)
- •Peptic ulcer history
- •Peptic ulcer, esophageal cancer, gastric cancer case found at EGD
- •H. pylori eradication treatment history
- •Previous serious side effect to antibiotics
- •Serious concurrent infection or nonmalignant disease such as liver cirrhosis, renal failure, cardiovascular diseases
- •Pregnant or nursing women
- •Psychiatric disorder that would preclude compliance, alcoholics
- •Refuse informed consent
研究组 & 干预措施
Placebo
Placebo for LAC triple therapy
干预措施: Placebo (Drug)
LAC triple therapy
PPI (Lansoprazole), Clarithromycin, Amoxicilline
干预措施: LAC triple therapy (Drug)
结局指标
主要结局
Gastric cancer incidence
时间窗: 6 years after last participant enrollment
The incidence of gastric cancer will be compared between the two arms as the participant assigned into either LAC treatment group or placebo group regardless the final H. pylori infection status. Currently, efficacy of LAC triple therapy shows about 75-85% eradication rate of the H. pylori.
次要结局
- Gastric cancer incidence according to H. pylori status(6 year after last participant enrollment)
- Gastric dysplasia incidence(6 year after last participant enrollment)
- Gastric cancer incidence between H. pylori treatment and H. pylori uninfected groups(6 year after last participant enrollment)
- All-cause mortality(6 year after last participant enrollment)
研究者
Il Ju Choi
M.D., Ph.D
National Cancer Center, Korea