Comparing H. pylori screening strategies to prevent gastric cancer
Official title: Identification of the Optimal Screening Strategy for Gastric Cancer Prevention
Run by National Taiwan University Hospital · NCT05387005 · Data updated 2026-11-12
This project will test different ways to screen adults (age ≥20) for H. pylori who have never been screened or treated.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 4403 (estimated) |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Status | Recruiting |
| Started | July 19, 2022 |
| Main results expected | April 30, 2027 |
| Study ends | April 30, 2029 |
| Registry record updated | August 17, 2025 |
| Trial ID | NCT05387005 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 20 years or older who have never been screened or treated for H. pylori, who have not had gastrectomy or gastric cancer, and who have not taken antibiotics or proton pump inhibitors within two weeks are ideal candidates.
✕Probably not a fit
People who have prior H. pylori testing or eradication therapy, a history of gastrectomy or gastric cancer, recent antibiotic or PPI use, or who cannot attend in-person testing visits are unlikely to benefit from joining this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an open-label, randomized study comparing four H. pylori diagnostic strategies: C13 urea breath test (UBT), H. pylori stool antigen (HpSA), both tests together, and a two-stage serology-first approach. The trial initially randomized participants 1:1:1:1 but an interim analysis led to stopping enrollment for the HpSA-only and two-stage groups; those groups enrolled 852 and 851 participants respectively. Enrollment continues for the UBT-only and combined-test groups with additional randomization until each of those arms reaches 1,350 participants. Primary outcomes include detection rate of H. pylori infection and participant adherence/acceptability of the screening methods, with accuracy compared across tests.
Why it matters
Potential benefit: If successful, this work could identify the most acceptable and accurate screening approach to increase detection of H. pylori and help reduce future gastric cancer risk.
How similar studies have gone: Population H. pylori screening programs in high-risk regions have shown promise for reducing gastric cancer, but direct randomized comparisons of UBT versus stool antigen or serology-based two-stage approaches are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 20 years or older * Never screened and treated for H. pylori infection Exclusion Criteria: * 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
Where it's running
-
National Taiwan University Hospital
Taipei, Taiwan Recruiting
Study contacts
- Study coordinator: Jyh-Ming Liou, MD,PhD
- Email: jyhmingliou@gmail.com
- Phone: 886-2-23123456
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.