Gastric Cancer Prevention for Indigenous Peoples

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03900910
Collaborator
Ministry of Health and Welfare, Taiwan (Other)
30,000
1
1
69
434.8

Study Details

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
  • Other: Gastric cancer prevention
N/A

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
Anticipated 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.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 :
Apr 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: 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 [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 [At least 5 years]

    To assess the eradication rate of anti-H. pylori treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT03900910
Other Study ID Numbers:
  • 201804108RINB
  • 1070056368
First Posted:
Apr 3, 2019
Last Update Posted:
Sep 5, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2021