Screening Strategy for Gastric Cancer Prevention

Recruiting now · Not applicable

Conditions studied: H. Pylori Infection

In brief

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.

Key facts

Study ID

NCT05387005

Run by

National Taiwan University Hospital

People needed

4403

Starts

2022-07-19

Expected to finish

2029-04-30

Last updated by the study team

2025-08-17

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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