NCT03900910

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50,000

participants targeted

Target at P75+ for not_applicable gastric-cancer

Timeline
56mo left

Started Jan 2018

Longer than P75 for not_applicable gastric-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Jan 2018Dec 2030

Study Start

First participant enrolled

January 1, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
11.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

13 years

First QC Date

April 1, 2019

Last Update Submit

January 18, 2026

Conditions

Gastric Cancer

Keywords

Cancer preventionAntibioticsInequality

Outcome Measures

Primary Outcomes (6)

  • 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.

  • Helicobacter eradication rate

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

    At least 5 years

  • The participation rate

    The number of participants divided by the number of invitees

    Screening program quality indicator

  • The positivity rate

    The number of positive test results divided by the number of participants

    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

    Screening program quality indicator

  • The reinfection rate

    The number of positive test results divided by the person-years of follow-up

    Screening program quality indicator

Study Arms (2)

Gastric cancer prevention

EXPERIMENTAL

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

Other: Gastric cancer preventionOther: 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.

Other: Gastric cancer preventionOther: Execution of the program

Interventions

Gastric cancer preventionOTHER

Participants will receive the 13C-urea breath test and those with test positive will further receive H. pylori eradication treatment.

Gastric cancer preventionThe acceptability and applicability of the mass screening program
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 .

Gastric cancer preventionThe acceptability and applicability of the mass screening program

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 20-60 years
  • Mentally competent to be able to understand the consent form
  • Able to communicate with study staff for individuals

You may not qualify if:

  • Pregnancy
  • Individuals with major comorbid diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 10002, Taiwan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37197905DERIVED

Related Links

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Yi-Chia Lee, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Chia Lee, MD, PhD

CONTACT

886-2-23123456yichialee@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Mass screening and eradication of Helicobacter pylori infection in Indigenous community.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2019

First Posted

April 3, 2019

Study Start

January 1, 2018

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

No individual participant data could be shared.

Locations

TW(1)