NCT05387005

Screening Strategy for Gastric Cancer Prevention

Identification of the Optimal Screening Strategy for Gastric Cancer Prevention

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,403 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

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

Conditions

• H. Pylori Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	UBT	H. pylori diagnostic test: C13 urea breath test
DIAGNOSTIC_TEST	HPSA	H. pylori diagnostic test: H. pylori stool antigen test
DIAGNOSTIC_TEST	UBT and HPSA	H. pylori diagnostic tests: H. pylori serology test, C13 urea breath test
DIAGNOSTIC_TEST	Serology (two stage)	H. pylori diagnostic test: If H. pylori serology is positive, confirmation UBT will be done.

Timeline

• Start date: 2022-07-19
• Primary completion: 2027-04-30
• Completion: 2029-04-30
• First posted: 2022-05-24
• Last updated: 2025-08-17

Locations

1 site across 1 country: Taiwan