Clinical trial NCT03900910: Gastric Cancer Prevention for Indigenous Peoples
Official title: A Gastric Cancer Prevention Program for Aboriginal People Living in the Remote Areas
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Gastric Cancer
Keywords: Cancer prevention
Antibiotics
Inequality
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Welfare, Taiwan
First posted: 2019-04-03
Enrollment: 30000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Mass screening and eradication of Helicobacter pylori infection in Indigenous community.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnancy
* Individuals with major comorbid diseases

Primary outcomes:
measure: Gastric cancer incidence
timeFrame: After at least 5 years, the gastric cancer incidence per 100,000 person-years is calculated by the person-years of follow-up.
measure: Helicobacter eradication rate
timeFrame: At least 5 years
measure: The participation rate
timeFrame: Screening program quality indicator
measure: The positivity rate
timeFrame: Screening program quality indicator
measure: The referral-to-treatment rate
timeFrame: Screening program quality indicator
measure: The reinfection rate
timeFrame: Screening program quality indicator
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yi-Chia Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: