Gastric Cancer Prevention for Indigenous Peoples

• ClinicalTrials.gov Identifier: NCT03900910
• Recruitment Status: Enrolling by invitation
• First Posted: April 3, 2019
• Last Update Posted: September 5, 2021
• Sponsor: National Taiwan University Hospital
• Collaborator: Ministry of Health and Welfare, Taiwan
• Information provided by (Responsible Party): National Taiwan University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gastric Cancer	Other: Gastric cancer prevention	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30000 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Mass screening and eradication of Helicobacter pylori infection in Indigenous community.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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
2. Helicobacter eradication rate [ Time Frame: At least 5 years ]
   To assess the eradication rate of anti-H. pylori treatment.

Eligibility Criteria

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

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

Contacts and Locations

Locations

Taiwan

National Taiwan University Hospital

Taipei City, Taiwan, 10002

Sponsors and Collaborators

National Taiwan University Hospital

Ministry of Health and Welfare, Taiwan

Investigators

• Principal Investigator: Yi-Chia Lee, MD, PhD; National Taiwan University Hospital

More Information

Additional Information:

Action Plans to Reduce Health Disparity in Indigenous Communities in Taiwan 

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT03900910
• Other Study ID Numbers: 201804108RINB; 1070056368 ( Other Identifier: Council of Indigenous Peoples in Taiwan )
• First Posted: April 3, 2019
• Last Update Posted: September 5, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No individual participant data could be shared.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Taiwan University Hospital:

Cancer prevention; Antibiotics; Inequality

Additional relevant MeSH terms:

Stomach Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases