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Screening Strategy for Gastric Cancer Prevention

NCT05387005 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4403

Last updated 2025-08-17

No results posted yet for this study

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.

Conditions

  • H. Pylori Infection

Interventions

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.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-19
Primary Completion
2027-04-30
Completion
2029-04-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05387005 on ClinicalTrials.gov