Screening Strategy for Gastric Cancer Prevention

Study Overview
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Brief Summary
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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
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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: 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

Official Title
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Identification of the Optimal Screening Strategy for Gastric Cancer Prevention

Conditions
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H. Pylori Infection

Intervention / Treatment
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* Diagnostic Test: UBT
* Diagnostic Test: HPSA
* Diagnostic Test: UBT and HPSA
* Diagnostic Test: Serology (two stage)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 10,000 adults of ≥20 years 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UBT<br> | Diagnostic Test: UBT<br>* H. pylori diagnostic test: C13 urea breath test<br>|
| Experimental: HpSA<br> | Diagnostic Test: HPSA<br>* H. pylori diagnostic test: H. pylori stool antigen test<br>|
| Experimental: Both<br> | Diagnostic Test: UBT and HPSA<br>* H. pylori diagnostic tests: H. pylori serology test, C13 urea breath test<br>|
| Experimental: Two-stage screening method<br> | Diagnostic Test: Serology (two stage)<br>* H. pylori diagnostic test: H. pylori serology test<br>|

What is the study measuring?
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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. | 2-3 years | 

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. | 2-3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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H. pylori, screening