Screening Strategy for Gastric Cancer Prevention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: UBT, HPSA, UBT and HPSA, Serology (two stage).
- Who it may be relevant to
- Registry conditions: H. Pylori Infection. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Identification of the Optimal Screening Strategy for Gastric Cancer Prevention
Overview
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
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.
Primary outcome measures
- Detection rates of H. pylori infection [Time frame: 2-8 weeks]
Secondary outcome measures (1)
- The compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups [Time frame: 2 weeks to 1 year]
Eligibility criteria
Inclusion criteria
- Adults aged 20 years or older
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT05387005 · 202203064RINC