Clinical trial NCT05387005: Screening Strategy for Gastric Cancer Prevention
Official title: Identification of the Optimal Screening Strategy for Gastric Cancer Prevention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: H. Pylori Infection
Keywords: H. pylori
screening
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 10000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: Detection rates of H. pylori infection
timeFrame: 2-3 years
Secondary outcomes:
measure: The compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups
timeFrame: 2-3 years
Other outcomes:
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