Screening Strategy for Gastric Cancer Prevention

Identification of the Optimal 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.

Study Overview

• Status: Recruiting
• Conditions: H. Pylori Infection
• Intervention / Treatment: Diagnostic test: UBT; Diagnostic test: HPSA; Diagnostic test: UBT and HPSA; Diagnostic test: Serology (two stage)

Detailed Description

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:

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

• Study Type: Interventional
• Enrollment (Estimated): 4403
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jyh-Ming Liou, MD,PhD; Phone Number: 63541 886-2-23123456; Email: jyhmingliou@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Jyh-Ming Liou Liou, MD, PhD; Phone Number: 886-2-23123456 Ext. 63541; Email: jyhmingliou@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UBT	Diagnostic test: UBT; H. pylori diagnostic test: C13 urea breath test
Experimental: HpSA	Diagnostic test: HPSA; H. pylori diagnostic test: H. pylori stool antigen test
Experimental: Two-stage screening method	Diagnostic test: Serology (two stage); H. pylori diagnostic test: If H. pylori serology is positive, confirmation UBT will be done.
Experimental: Standard method	Diagnostic test: UBT and HPSA; H. pylori diagnostic tests: H. pylori serology test, C13 urea breath test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection rates of H. pylori infection	The positivity rate of H. pylori infection between different study arms, respectively in ITT and PP analysis.	2-8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups	Completion rates of the study (from enrollment to the diagnosis of H. pylori; from enrollment to the treatment of H. pylori infection.	2 weeks to 1 year

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2022
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2029

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: May 22, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: screening; H. pylori
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 202203064RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No