Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT05387005
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.
Initially, we planned to recruit 10,000 adults aged ≥20 years who had not previously undergone H. pylori screening or treatment. Eligible participants were to be randomly allocated in a 1:1:1:1 ratio to one of four groups, each receiving a different combination of diagnostic tests. However, a preliminary analysis led to a recalculation of the required sample size. Following the approval of an Institutional Review Board (IRB) amendment, enrollment was discontinued for Group B (HpSA method) and Group D (Two-stage screening method). The final number of participants enrolled in Group B and Group D was 852 and 851, respectively. Groups A (UBT method) and Group C (standard method) will continue to enroll participants through an additional 1:1 randomization until each group reaches a total of 1,350 participants.
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 Initially, the investigators will recruit adults with age of ≥20 years who have not received H. pylori screening or treatment. Eligible patients were 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) Standard method (Both C13 UBT and HpSA), (D) Two-stage screening method (serology screening only, and then C13 UBT for confirmation if serology test is positive). However, a preliminary analysis led to a recalculation of the required sample size. Following the approval of an Institutional Review Board (IRB) amendment, enrollment was discontinued for Group B and Group D. The final number of participants enrolled in Group B and Group D was 852 and 851, respectively. Groups A and Group C will continue to enroll participants through an additional 1:1 randomization until each group reaches a total of 1,350 participants.
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:
NCT05387005
Study Brief:
Protocol Section:
NCT05387005