跳至主要内容
临床试验/NCT02663427
NCT02663427Unknown不适用

Serological Screening of Gastric Cancer in Wuxi Region

Wuxi People's Hospital0 个研究点目标入组 5,000 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
5,000
主要终点
detection rate of gastric cancer among all group

研究概览

简要总结

The purpose of this study is to determine whether detection of pepsinogen Ⅰand Ⅱ combined with Helicobacter pylori antibody, so-called ABC method , is fit on gastric cancer screening in community of Wuxi City.

详细描述

Gastric cancer is the third largest cause of cancer related deaths in China with about 350 ,000 gastric cancer-related deaths by gastric cancer in 2012. The studies from Japan and Korea have found gastric cancer screening, especially of the mass population, reduces mortality from gastric cancer, but the data is seldom in China. The ways include radiographic and endoscopic screening, although those methods were shown to reduce gastric cancer mortality, and was recommended as gold standard for population-based screening by Japan and Korea, but many problems have been pointed out: A serious drawback is low uptake of the target population; fear for radiation exposure(0.6 mSv), swallowing unpleasantness due to the use of barium meal, accidental fall during the examination and constipation, causing rare but more serious complications such as intestinal obstruction or diverticulitis after examination may account for the reasons for this low uptake, endoscopic screening is labor-intensive, more costly per examination as complete disinfection of the scope is mandatory, and requires a large number of well-trained experienced endoscopists.

Serological method, so-called ABC method , has been useful as gastric cancer preliminary screening in some areas, such as China, Japan and Korea. The major reasons are attributed to its simplicity, safety (radiation-free, discomfort free), and cost-efficiency. The ABC method is a blood test to stratify the risk of gastric cancer using the combination of H. pylori antibody and pepsinogen I and II, that was documented by large-scale studies in Japan. But the data was short in China, especially in the community.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 40-70 years old, men and women are not limited, and there are one of the following:
  • Hp infected.
  • Previously suffering from chronic atrophic gastritis, gastric ulcer, gastric polyps, hypertrophic gastritis, pernicious anemia and other precancerous diseases of the stomach.
  • First degree relatives of patients with gastric cancer.
  • Other risk factors for gastric cancer. (high salt, salted diet, smoking, heavy drinking, etc.)

排除标准

  • Severe heart, liver, kidney, dysfunction or mental disorders
  • History of gastric surgery (including surgery, minimally invasive EMR, ESD)
  • Use of PPI, acid preparation, stomach protecting agent in the first two weeks
  • The researchers considered inappropriate participants.
  • Informed consent cannot be attained

结局指标

主要结局

detection rate of gastric cancer among all group

时间窗: through study completion, an average of 1 year

次要结局

未报告次要终点

研究者

发起方
Wuxi People's Hospital
申办方类型
Other
责任方
Sponsor

相似试验