Gastric Cancer Prevention for Indigenous Peoples
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|ClinicalTrials.gov Identifier: NCT03900910|
Recruitment Status : Enrolling by invitation
First Posted : April 3, 2019
Last Update Posted : April 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Other: Gastric cancer prevention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30000 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Mass screening and eradication of Helicobacter pylori infection in Indigenous community.|
|Masking:||None (Open Label)|
|Official Title:||A Gastric Cancer Prevention Program for Aboriginal People Living in the Remote Areas|
|Actual Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Gastric cancer prevention
13C-urea breath test and anti-H. pylori treatment for those who are tested positive.
Other: Gastric cancer prevention
Participants will receive the 13C-urea breath test and those with test positive will further receive H. pylori eradication treatment.
- Gastric cancer incidence [ Time Frame: 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 [ Time Frame: At least 5 years ]To assess the eradication rate of anti-H. pylori treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03900910
|National Taiwan University Hospital|
|Taipei City, Taiwan, 10002|
|Principal Investigator:||Yi-Chia Lee, MD, PhD||National Taiwan University Hospital|