跳至主要内容
临床试验/NCT03900910
NCT03900910Enrolling By Invitation不适用

A Gastric Cancer Prevention Program for Aboriginal People Living in the Remote Areas

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 30,000 人开始时间: 2018年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
30,000
试验地点
1
主要终点
Gastric cancer incidence

研究概览

简要总结

The incidence of gastric cancer in local indigenous peoples is higher than the non-Indigenous counterpart in Taiwan. How to design an effective prevention strategy for gastric cancer is of importance. The present study aimed to identify the causes that may account for the health inequalities, allowing generation of a plan of action on the whole population scale.

详细描述

Owing to the continuing gap in cancer burden between Indigenous and non-Indigenous peoples, reducing health disparities has drawn worldwide attention. Evidence indicates that the gastric cancer incidence and mortality rates in Indigenous peoples are much higher than those of non-Indigenous counterparts living in the same areas. Exposure to more risk factors from social habits, lifestyle, and Helicobacter pylori infection has been considered the cause. However, even though gastric cancer has been repeatedly shown to be preventable by eliminating risk factors, eradication policies are rarely designed for Indigenous peoples. Possible obstacles may include the lack of Indigenous health statistics, inadequate access to care, difficulty in modifying social habits and lifestyles, and the presence of environmental and cultural barriers. Developing and implementing a preventive strategy following the evidence-based principle remains a challenge.

In Taiwan, the number of Indigenous peoples has grown; however, their life expectancy remains substantially lower than that of the non-Indigenous population. Cancer is the most prevalent cause of death for Indigenous peoples and a disproportionate prevalence of certain kinds of cancer is noted for Indigenous peoples. These observations provide an opportunity to establish a plan of action, in which a specific intervention is developed to decrease the threat from each specific cancer so that the overall disparate burden can be reduced in a stepwise manner.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Aged 20-60 years
  • •Mentally competent to be able to understand the consent form
  • •Able to communicate with study staff for individuals

排除标准

  • •Pregnancy
  • •Individuals with major comorbid diseases

研究组 & 干预措施

Gastric cancer prevention

Experimental

13C-urea breath test and anti-H. pylori treatment for those who are tested positive.

干预措施: Gastric cancer prevention (Other)

Gastric cancer prevention

Experimental

13C-urea breath test and anti-H. pylori treatment for those who are tested positive.

干预措施: Execution of the program (Other)

The acceptability and applicability of the mass screening program

Experimental

Our short-term outcome is the acceptability and feasibility of this screening program, which will be evaluated by answering whether the screening quality indicators can reach the minimal requirements.

干预措施: Gastric cancer prevention (Other)

The acceptability and applicability of the mass screening program

Experimental

Our short-term outcome is the acceptability and feasibility of this screening program, which will be evaluated by answering whether the screening quality indicators can reach the minimal requirements.

干预措施: Execution of the program (Other)

结局指标

主要结局

Gastric cancer incidence

时间窗: After at least 5 years, the gastric cancer incidence per 100,000 person-years is calculated by the person-years of follow-up.

To assess the effect of H. pylori eradication for gastric cancer prevention

Helicobacter eradication rate

时间窗: At least 5 years

To assess the eradication rate of anti-H. pylori treatment.

The participation rate

时间窗: Screening program quality indicator

The number of participants divided by the number of invitees

The positivity rate

时间窗: Screening program quality indicator

The number of positive test results divided by the number of participants

The referral-to-treatment rate

时间窗: Screening program quality indicator

The number of individuals who received anti-H pylori treatment divided by the number of positive test results

The reinfection rate

时间窗: Screening program quality indicator

The number of positive test results divided by the person-years of follow-up

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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