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NCT Number: NCT05387005

Screening Strategy for Gastric Cancer Prevention

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.

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Key information

Conditions

H. Pylori Infection

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Location status: Recruiting

Location contact

Jyh-Ming Liou Liou, MD, PhD

CONTACT

[email protected]

886-2-23123456 Ext. 63541

About this study

Background: 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.

Objective: A prospective, randomized trial will be conducted to compare the acceptability, compliance (/adherence), and accuracy of C13 UBT and HpSA in a population-based H. pylori screening and gastric cancer prevention program.

Methods：Open labeled, randomized controlled trial Initially, the investigators will recruit adults with age of ≥20 years who have not received H. pylori screening or treatment. Eligible patients were randomly 1:1:1:1 allocated to (A) The carbon-13 urea breath test (C13 UBT), (B) H. pylori stool antigen test (Vstrip® HpSA), (C) Standard method (Both C13 UBT and HpSA), (D) Two-stage screening method (serology screening only, and then C13 UBT for confirmation if serology test is positive). 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 and Group D. The final number of participants enrolled in Group B and Group D was 852 and 851, respectively. Groups A and Group C will continue to enroll participants through an additional 1:1 randomization until each group reaches a total of 1,350 participants.

Outcome analysis:

  • Detection rate of H. pylori infection
  • To compare the compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups.
  • To assess the diagnostic accuracy of these tests.
  • To verify the compliance(/adherence) and feasibility of this two-stage screening method
  • Long-term Outcomes: To assess the risk reduction of gastric cancer

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UBT

Diagnostic Test

H. pylori diagnostic test: C13 urea breath test

HPSA

Diagnostic Test

H. pylori diagnostic test: H. pylori stool antigen test

UBT and HPSA

Diagnostic Test

H. pylori diagnostic tests: H. pylori serology test, C13 urea breath test

Serology (two stage)

Diagnostic Test

H. pylori diagnostic test: If H. pylori serology is positive, confirmation UBT will be done.

Primary outcomes

  1. Detection rates of H. pylori infection

    Time frame: 2-8 weeks

    The positivity rate of H. pylori infection between different study arms, respectively in ITT and PP analysis.

Secondary outcomes

  1. The compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups

    Time frame: 2 weeks to 1 year

    Completion rates of the study (from enrollment to the diagnosis of H. pylori; from enrollment to the treatment of H. pylori infection.

Study contacts

Contact information is provided by the study sponsor or research team.

Jyh-Ming Liou, MD,PhD

CONTACT

[email protected]

886-2-23123456 ext. 63541

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Identification of the Optimal Screening Strategy for Gastric Cancer Prevention

Important dates

Study start
2022
Primary completion
2027
Study completion
2029
First posted
May 24, 2022
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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