Gastric Cancer Prevention for Indigenous Peoples

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03900910
• Other study ID #: 201804108RINB
• Secondary ID: 1070056368
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2022
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Other:
• Gastric cancer prevention
Participants will receive the 13C-urea breath test and those with test positive will further receive H. pylori eradication treatment.
• 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 .

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei City

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Ministry of Health and Welfare, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Helicobacter eradication rate	To assess the eradication rate of anti-H. pylori treatment.	At least 5 years
Primary	The participation rate	The number of participants divided by the number of invitees	Screening program quality indicator
Primary	The positivity rate	The number of positive test results divided by the number of participants	Screening program quality indicator
Primary	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
Primary	The reinfection rate	The number of positive test results divided by the person-years of follow-up	Screening program quality indicator

External Links

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