Screening Strategy for Gastric Cancer Prevention

National Taiwan University

Status: Not yet enrolling

Conditions: H. Pylori Infection

Treatments: Diagnostic Test: HPSA; Diagnostic Test: Serology (two stage); Diagnostic Test: UBT; Diagnostic Test: UBT and HPSA

Study type: Interventional

Funder types: Other

Identifiers

NCT05387005

202203064RINC

Details and patient eligibility

About

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.

Full 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

Enrollment: 10,000 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10,000 participants in 4 patient groups

UBT

Experimental group

Treatment:

Diagnostic Test: UBT

HpSA

Experimental group

Treatment:

Diagnostic Test: HPSA

Both

Experimental group

Treatment:

Diagnostic Test: UBT and HPSA

Two-stage screening method

Experimental group

Treatment:

Diagnostic Test: Serology (two stage)