Gastric Cancer Prevention for Indigenous Peoples

Not Applicable

• Conditions: Gastric Cancer
• Interventions: Other: Gastric cancer prevention; Other: Execution of the program

• Registration Number: NCT03900910
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2019-04-01
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-03
• Status Verified: 2022-09
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-14
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30000

Inclusion Criteria

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

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Exclusion Criteria

• Pregnancy
• Individuals with major comorbid diseases

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The acceptability and applicability of the mass screening program	Execution of the program	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.
The acceptability and applicability of the mass screening program	Gastric cancer prevention	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.
Gastric cancer prevention	Gastric cancer prevention	13C-urea breath test and anti-H. pylori treatment for those who are tested positive.
Gastric cancer prevention	Execution of the program	13C-urea breath test and anti-H. pylori treatment for those who are tested positive.

Primary Outcome Measures

Name	Time	Method
Gastric cancer incidence	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	At least 5 years	To assess the eradication rate of anti-H. pylori treatment.
The participation rate	Screening program quality indicator	The number of participants divided by the number of invitees
The positivity rate	Screening program quality indicator	The number of positive test results divided by the number of participants
The referral-to-treatment rate	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	Screening program quality indicator	The number of positive test results divided by the person-years of follow-up

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei City, Taiwan