Screening Strategy for Gastric Cancer Prevention

Status Not yet recruiting

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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05387005
Study type	Interventional
Source	National Taiwan University Hospital
Contact	Jyh-Ming Liou, MD,PhD
Phone	886-2-23123456
Email	jyhmingliou@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	May 30, 2022
Completion date	March 31, 2026

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.