Gastric Cancer Prevention for Indigenous Peoples

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Gastric Cancer
• Intervention / Treatment: Other: Gastric cancer prevention; Other: Execution of the program

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 Type: Interventional
• Enrollment (Anticipated): 30000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City, Taiwan, 10002
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.; Other: Execution of the program; 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 .
Experimental: The acceptability and applicability of the mass screening 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.	Other: Gastric cancer prevention; Participants will receive the 13C-urea breath test and those with test positive will further receive H. pylori eradication treatment.; Other: Execution of the program; 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 .

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Ministry of Health and Welfare, Taiwan
• Investigators: Principal Investigator: Yi-Chia Lee, MD, PhD, National Taiwan University Hospital

Publications and helpful links

Helpful Links

• Action Plans to Reduce Health Disparity in Indigenous Communities in Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (Actual): April 3, 2019

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Antibiotics; Cancer prevention; Inequality
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 201804108RINB; 1070056368 (Other Identifier: Council of Indigenous Peoples in Taiwan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data could be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No