Gastric CancerNCT03900910
Gastric Cancer Prevention for Indigenous Peoples
A study testing Gastric cancer prevention and Execution of the program in people with Gastric Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Gastric cancer prevention and Execution of the program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2018to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 20-60 years
- Mentally competent to be able to understand the consent form
- Able to communicate with study staff for individuals
Who cannot join
- Pregnancy
- Individuals with major comorbid diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 10002
Yi-Chia Lee, MD, PhD, 886-2-23123456 ext. 63351, yichialee@ntu.edu.tw
About this study
Official title: A Gastric Cancer Prevention Program for Aboriginal People Living in the Remote Areas
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.
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- Gastric cancer prevention, Execution of the program
- Keywords
- Cancer prevention, Antibiotics, Inequality
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric cancer preventionOther
Participants will receive the 13C-urea breath test and those with test positive will further receive H. pylori eradication treatment.
Execution of the programOther
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 .
| Study group | Role | What they receive |
|---|---|---|
| Gastric cancer prevention | Experimental | 13C-urea breath test and anti-H. pylori treatment for those who are tested positive. Receives: Other: Gastric cancer prevention; Other: Execution of the program |
| The acceptability and applicability of the mass screening program | Experimental | 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. Receives: Other: Gastric cancer prevention; Other: Execution of the program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric cancer incidence
To assess the effect of H. pylori eradication for gastric cancer prevention
Measured: After at least 5 years, the gastric cancer incidence per 100,000 person-years is calculated by the person-years of follow-up.
Helicobacter eradication rate
To assess the eradication rate of anti-H. pylori treatment.
Measured: At least 5 years
The participation rate
The number of participants divided by the number of invitees
Measured: Screening program quality indicator
The positivity rate
The number of positive test results divided by the number of participants
Measured: Screening program quality indicator
The referral-to-treatment rate
The number of individuals who received anti-H pylori treatment divided by the number of positive test results
Measured: Screening program quality indicator
The reinfection rate
The number of positive test results divided by the person-years of follow-up
Measured: Screening program quality indicator
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start1 Jan 2018
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Mass screening and eradication of Helicobacter pylori infection in Indigenous community.
- Masking
- None (open label)
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Responsible party
- Sponsor
- Investigators
- Yi-Chia Lee, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900910
- Sponsor's protocol ID
- 201804108RINB
- Other IDs
- 1070056368
- Status last verified
- Jan 2026
- First submitted
- 1 Apr 2019
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data could be shared.
Publications
Lei WY, Lee JY, Chuang SL, Bair MJ, Chen CL, Wu JY, Wu DC, Tien O'Donnell F, Tien HW, Chen YR, Chiang TH, Hsu YH, Hsu TH, Hsieh PC, Lin LJ, Chia SL, Wu CC, Subeq YM, Wen SH, Chang HC, Lin YW, Sun KP, Chu CH, Wu MS, Graham DY, Chen HH, Lee YC. Eradicating Helicobacter pylori via 13C-urea breath screening to prevent gastric cancer in indigenous communities: a population-based study and development of a family index-case method. Gut. 2023 Nov 24;72(12):2231-2240. doi: 10.1136/gutjnl-2023-329871.
PubMed 37197905
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Gastric Cancer Prevention Program for Aboriginal People Living in the Remote Areas
- ClinicalTrials.gov ID
- NCT03900910
- Acronym / sponsor ID
- 201804108RINB
- Conditions
- Gastric Cancer
- Keywords
- Cancer prevention, Antibiotics, Inequality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mass screening and eradication of Helicobacter pylori infection in Indigenous community.
| Arm | Type | Receives |
|---|---|---|
| Gastric cancer prevention | Experimental | Other: Gastric cancer prevention, Other: Execution of the program13C-urea breath test and anti-H. pylori treatment for those who are tested positive. |
| The acceptability and applicability of the mass screening program | Experimental | Other: Gastric cancer prevention, Other: Execution of the programOur 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 20-60 years
- Mentally competent to be able to understand the consent form
- Able to communicate with study staff for individuals
Key exclusion criteria (2 listed)
- Pregnancy
- Individuals with major comorbid diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric cancer preventionParticipants will receive the 13C-urea breath test and those with test positive will further receive H. pylori eradication treatment. | Other | Gastric cancer prevention, The acceptability and applicability of the mass screening program |
| Execution of the programScreening program is audited by the standardized quality indicators, including the participation rate, the positivity rate, the referral-to-treatment rate, and the eradication rate . | Other | Gastric cancer prevention, The acceptability and applicability of the mass screening program |
Primary outcome
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
Helicobacter eradication rate
Time frame: At least 5 years
To assess the eradication rate of anti-H. pylori treatment.
The participation rate
Time frame: Screening program quality indicator
The number of participants divided by the number of invitees
The positivity rate
Time frame: Screening program quality indicator
The number of positive test results divided by the number of participants
The referral-to-treatment rate
Time frame: Screening program quality indicator
The number of individuals who received anti-H pylori treatment divided by the number of positive test results
The reinfection rate
Time frame: Screening program quality indicator
The number of positive test results divided by the person-years of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Derived from this study: PubMed 37197905Lei WY, Lee JY, Chuang SL, Bair MJ, Chen CL, Wu JY, Wu DC, Tien O'Donnell F, Tien HW, Chen YR, Chiang TH, Hsu YH, Hsu TH, Hsieh PC, Lin LJ, Chia SL, Wu CC, Subeq YM, Wen SH, Chang HC, Lin YW, Sun KP, Chu CH, Wu MS, Graham DY, Chen HH, Lee YC. Eradicating Helicobacter pylori via 13C-urea breath screening to prevent gastric cancer in indigenous communities: a population-based study and development of a family index-case method. Gut. 2023 Nov 24;72(12):2231-2240. doi: 10.1136/gutjnl-2023-329871.
- Action Plans to Reduce Health Disparity in Indigenous Communities in TaiwanLink provided by the sponsor.
- Individual participant dataSharing planned: No. No individual participant data could be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yi-Chia Lee, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric cancer prevention and Execution of the program in people with Gastric Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi-Chia Lee, MD, PhD (886-2-23123456 ext. 63351, yichialee@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03900910, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.