Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
Healthy Volunteers
ID05387005

Identification of the Optimal Screening Strategy for Gastric Cancer Prevention

Led by National Taiwan University Hospital · Updated on 2025-08-17

4403

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a prospective, randomized trial to find the best way to screen for H. pylori infection to help prevent gastric cancer. The study compares different screening methods to understand which tests are most acceptable, accurate, and followed well by adults aged 20 years and older who have not previously been screened or treated for H. pylori infection. Participants are randomly placed into groups receiving one of four diagnostic test methods: the carbon-13 urea breath test (UBT), the H. pylori stool antigen test (HpSA), a standard method combining both UBT and HpSA, or a two-stage screening starting with serology followed by confirmation with UBT if positive. Enrollment for the HpSA and two-stage groups has been stopped after initial analysis, and the study continues enrolling participants for the UBT and standard method groups to reach their target numbers. During the study, participants will undergo these screening tests with follow-up assessments over a period from 2 weeks up to 1 year to measure detection rates of H. pylori infection and adherence to the screening. Researchers will monitor compliance and diagnostic accuracy, and assess the potential long-term impact on reducing gastric cancer risk. The study participation duration and testing schedules are designed to collect detailed data on test performance and acceptability.

CONDITIONS

Brief Title

Screening Strategy for Gastric Cancer Prevention

Who Can Participate

Age: 20Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 20 years or older
  • Never screened and treated for H. pylori infection
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - 2 to 8 weeks

Participants undergo diagnostic tests to detect H. pylori infection using different screening methods such as the C13 urea breath test, H. pylori stool antigen test, or a two-stage screening involving serology followed by breath test confirmation.

1 to 2 visits depending on assigned screening method

Long-term Monitoring

Duration - 2 weeks to 1 year

Participants' compliance to the screening tests and the long-term outcomes related to gastric cancer risk reduction are observed and assessed.

Periodic visits over up to 1 year

Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital

Taipei, Taiwan

Actively Recruiting

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Research Team

J

Jyh-Ming Liou, MD,PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

4

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Frequently Asked Questions

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