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Gastric Cancer Prevention for Indigenous Peoples

Primary Purpose

Gastric Cancer

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Gastric cancer prevention
Execution of the program
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Cancer prevention, Antibiotics, Inequality

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Gastric cancer prevention

The acceptability and applicability of the mass screening program

Arm Description

13C-urea breath test and anti-H. pylori treatment for those who are tested positive.

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.

Outcomes

Primary Outcome Measures

Gastric cancer incidence
To assess the effect of H. pylori eradication for gastric cancer prevention
Helicobacter eradication rate
To assess the eradication rate of anti-H. pylori treatment.
The participation rate
The number of participants divided by the number of invitees
The positivity rate
The number of positive test results divided by the number of participants
The referral-to-treatment rate
The number of individuals who received anti-H pylori treatment divided by the number of positive test results
The reinfection rate
The number of positive test results divided by the person-years of follow-up

Secondary Outcome Measures

Full Information

First Posted
April 1, 2019
Last Updated
March 13, 2023
Sponsor
National Taiwan University Hospital
Collaborators
Ministry of Health and Welfare, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03900910
Brief Title
Gastric Cancer Prevention for Indigenous Peoples
Official Title
A Gastric Cancer Prevention Program for Aboriginal People Living in the Remote Areas
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Ministry of Health and Welfare, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Cancer prevention, Antibiotics, Inequality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Mass screening and eradication of Helicobacter pylori infection in Indigenous community.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gastric cancer prevention
Arm Type
Experimental
Arm Description
13C-urea breath test and anti-H. pylori treatment for those who are tested positive.
Arm Title
The acceptability and applicability of the mass screening program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Gastric cancer prevention
Intervention Description
Participants will receive the 13C-urea breath test and those with test positive will further receive H. pylori eradication treatment.
Intervention Type
Other
Intervention Name(s)
Execution of the program
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Gastric cancer incidence
Description
To assess the effect of H. pylori eradication for gastric cancer prevention
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.
Title
Helicobacter eradication rate
Description
To assess the eradication rate of anti-H. pylori treatment.
Time Frame
At least 5 years
Title
The participation rate
Description
The number of participants divided by the number of invitees
Time Frame
Screening program quality indicator
Title
The positivity rate
Description
The number of positive test results divided by the number of participants
Time Frame
Screening program quality indicator
Title
The referral-to-treatment rate
Description
The number of individuals who received anti-H pylori treatment divided by the number of positive test results
Time Frame
Screening program quality indicator
Title
The reinfection rate
Description
The number of positive test results divided by the person-years of follow-up
Time Frame
Screening program quality indicator

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 Individuals with major comorbid diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Chia Lee, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
10002
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data could be shared.
Links:
URL
https://dep.mohw.gov.tw/DONAHC/lp-3949-104.html
Description
Action Plans to Reduce Health Disparity in Indigenous Communities in Taiwan

Learn more about this trial

Gastric Cancer Prevention for Indigenous Peoples

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