Gastric Cancer Prevention for Indigenous Peoples

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastric Cancer

Intervention / Treatment
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* Other: Gastric cancer prevention
* Other: Execution of the program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Mass screening and eradication of Helicobacter pylori infection in Indigenous community.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gastric cancer prevention<br>13C-urea breath test and anti-H. pylori treatment for those who are tested positive. | Other: Gastric cancer prevention<br>* Participants will receive the 13C-urea breath test and those with test positive will further receive H. pylori eradication treatment.<br>Other: Execution of the program<br>* Screening program is audited by the standardized quality indicators, including the participation rate, the positivity rate, the referral-to-treatment rate, and the eradication rate .<br>|
| Experimental: The acceptability and applicability of the mass screening program<br>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. | Other: Gastric cancer prevention<br>* Participants will receive the 13C-urea breath test and those with test positive will further receive H. pylori eradication treatment.<br>Other: Execution of the program<br>* Screening program is audited by the standardized quality indicators, including the participation rate, the positivity rate, the referral-to-treatment rate, and the eradication rate .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric cancer incidence | To assess the effect of H. pylori eradication for gastric cancer prevention | After at least 5 years, the gastric cancer incidence per 100,000 person-years is calculated by the person-years of follow-up. | 
| Helicobacter eradication rate | To assess the eradication rate of anti-H. pylori treatment. | At least 5 years | 
| The participation rate | The number of participants divided by the number of invitees | Screening program quality indicator | 
| The positivity rate | The number of positive test results divided by the number of participants | Screening program quality indicator | 
| The referral-to-treatment rate | The number of individuals who received anti-H pylori treatment divided by the number of positive test results | Screening program quality indicator | 
| The reinfection rate | The number of positive test results divided by the person-years of follow-up | Screening program quality indicator | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer prevention, Antibiotics, Inequality