Screening Strategy for Gastric Cancer Prevention
Identification of the Optimal Screening Strategy for Gastric Cancer Prevention
1 other identifier
interventional
4,403
1 country
1
Brief Summary
There are still some unsolved questions regarding population-based screening program for H. pylori infection to prevent gastric cancer, such as how to perform the optimal screening strategies. A prospective, randomized trial will be conducted to compare the acceptability, compliance (/adherence), and accuracy of diagnostic tests in a population-based H. pylori screening and gastric cancer prevention program. Initially, we planned to recruit 10,000 adults aged ≥20 years who had not previously undergone H. pylori screening or treatment. Eligible participants were to be randomly allocated in a 1:1:1:1 ratio to one of four groups, each receiving a different combination of diagnostic tests. However, a preliminary analysis led to a recalculation of the required sample size. Following the approval of an Institutional Review Board (IRB) amendment, enrollment was discontinued for Group B (HpSA method) and Group D (Two-stage screening method). The final number of participants enrolled in Group B and Group D was 852 and 851, respectively. Groups A (UBT method) and Group C (standard method) will continue to enroll participants through an additional 1:1 randomization until each group reaches a total of 1,350 participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2022
CompletedFirst Posted
Study publicly available on registry
May 24, 2022
CompletedStudy Start
First participant enrolled
July 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2029
August 17, 2025
August 1, 2025
4.8 years
April 28, 2022
August 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Detection rates of H. pylori infection
The positivity rate of H. pylori infection between different study arms, respectively in ITT and PP analysis.
2-8 weeks
Secondary Outcomes (1)
The compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups
2 weeks to 1 year
Study Arms (4)
UBT
EXPERIMENTALHpSA
EXPERIMENTALStandard method
EXPERIMENTALTwo-stage screening method
EXPERIMENTALInterventions
H. pylori diagnostic tests: H. pylori serology test, C13 urea breath test
H. pylori diagnostic test: If H. pylori serology is positive, confirmation UBT will be done.
Eligibility Criteria
You may qualify if:
- Adults aged 20 years or older
- Never screened and treated for H. pylori infection
You may not qualify if:
- Ever undergone gastrectomy
- Patients with gastric cancer
- Have been screened or tested for H. pylori infection
- Ever received H. pylori eradication therapy
- Have taken proton pump inhibitor within two weeks
- Have taken antibiotics within two weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Taiwan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2022
First Posted
May 24, 2022
Study Start
July 19, 2022
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
April 30, 2029
Last Updated
August 17, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share