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NCT05387005 Clinical Trial

Screening Strategy for Gastric Cancer Prevention

H. Pylori Infection Clinical Trial

Official title:
Identification of the Optimal Screening Strategy for Gastric Cancer Prevention

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05387005
Other study ID # 202203064RINC
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 30, 2022
Est. completion date March 31, 2026

Study information
Verified date April 2022
Source National Taiwan University Hospital
Contact Jyh-Ming Liou, MD,PhD
Phone 886-2-23123456
Email jyhmingliou@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 10000
Est. completion date March 31, 2026
Est. primary completion date March 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• UBT
H. pylori diagnostic test: C13 urea breath test
• HPSA
H. pylori diagnostic test: H. pylori stool antigen test
• UBT and HPSA
H. pylori diagnostic tests: H. pylori serology test, C13 urea breath test
• Serology (two stage)
H. pylori diagnostic test: H. pylori serology test

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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