Comparing H. pylori screening strategies to prevent gastric cancer

Identification of the Optimal Screening Strategy for Gastric Cancer Prevention

This project will test different ways to screen adults (age ≥20) for H. pylori who have never been screened or treated.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 4403 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: National Taiwan University Hospital (other)
• Locations: 1 site (Taipei)
• Trial ID: NCT05387005 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Taipei

• National Taiwan University Hospital — Taipei, Taiwan (RECRUITING)

Study contacts

• Study coordinator: Jyh-Ming Liou, MD,PhD

Conditions: H. Pylori Infection, H. pylori, screening