Screening Strategy for Gastric Cancer Prevention

Not Applicable

Not yet recruiting

• Conditions: H. Pylori Infection
• Interventions: Diagnostic Test: UBT; Diagnostic Test: UBT and HPSA; Diagnostic Test: Serology (two stage); Diagnostic Test: HPSA

• Registration Number: NCT05387005
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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. The investigators will recruit 10,000 adults with age of ≥20 years who have not received H. pylori screening or treatment. Eligible patients will be randomly 1:1:1:1 allocated to four groups with different combination tests.

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 The investigators will recruit 10,000 adults with age of ≥20 years who have not received H. pylori screening or treatment. Eligible patients will be 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) Both C13 UBT and HpSA, (D) Two-stage screening method (serology screening only, and then C13 UBT for confirmation if serology test is positive).

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

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-28
• Study First Submitted QC: 2022-05-22
• Study First Posted: 2022-05-24
• Last Update Submitted: 2022-05-24
• Study Start: 2022-05-30
• Last Update Posted: 2022-05-31
• Primary Completion: 2025-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• 10,000 adults of ≥20 years
• Never screened and treated for H. pylori infection

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UBT	UBT	-
Both	UBT and HPSA	-
Two-stage screening method	Serology (two stage)	-
HpSA	HPSA	-

Primary Outcome Measures

Name	Time	Method
Detection rates of H. pylori infection	2-3 years	The positivity rate of H. pylori infection between different study arms, respectively in ITT and PP analysis.

Secondary Outcome Measures

Name	Time	Method
The compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups	2-3 years	Completion rates of the study (from enrollment to the diagnosis of H. pylori; from enrollment to the treatment of H. pylori infection.