Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Gastric Cancer Prevention for Indigenous Peoples

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03900910
Recruitment Status : Enrolling by invitation
First Posted : April 3, 2019
Last Update Posted : April 3, 2019
Sponsor:
Collaborator:
Ministry of Health and Welfare, Taiwan
Information provided by (Responsible Party):
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.

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30000 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03900910


Locations
Layout table for location information
Taiwan
National Taiwan University Hospital
Taipei City, Taiwan, 10002
Sponsors and Collaborators
National Taiwan University Hospital
Ministry of Health and Welfare, Taiwan
Investigators
Layout table for investigator information
Principal Investigator: Yi-Chia Lee, MD, PhD National Taiwan University Hospital

Additional Information:
Layout table for additonal information
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03900910     History of Changes
Other Study ID Numbers: 201804108RINB
1070056368 ( Other Identifier: Council of Indigenous Peoples in Taiwan )
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data could be shared.

Layout table for additional information
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:
Layout table for MeSH terms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases