H. Pylori InfectionNCT05387005
Screening Strategy for Gastric Cancer Prevention
A study testing UBT, HPSA and UBT and HPSA in people with H. Pylori Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- H. Pylori Infection
- What is being tested?
- UBT, HPSA and UBT and HPSA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,403 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Jul 2022to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 20 years or older
- Never screened and treated for H. pylori infection
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Jyh-Ming Liou Liou, MD, PhD, 886-2-23123456 Ext. 63541, jyhmingliou@gmail.com
About this study
Official title: Identification of the Optimal Screening Strategy for Gastric Cancer Prevention
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.
Read the 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:
- Detection rate of H. pylori infection
- To compare the compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups.
- To assess the diagnostic accuracy of these tests.
- To verify the compliance(/adherence) and feasibility of this two-stage screening method
- Long-term Outcomes: To assess the risk reduction of gastric cancer
- Conditions
- H. Pylori Infection
- Being tested
- UBT, HPSA, UBT and HPSA, Serology (two stage)
- Keywords
- H. pylori, screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UBTDiagnostic test
- pylori diagnostic test: C13 urea breath test
HPSADiagnostic test
- pylori diagnostic test: H. pylori stool antigen test
UBT and HPSADiagnostic test
- pylori diagnostic tests: H. pylori serology test, C13 urea breath test
Serology (two stage)Diagnostic test
- pylori diagnostic test: If H. pylori serology is positive, confirmation UBT will be done.
| Study group | Role | What they receive |
|---|---|---|
| UBT | Experimental | Not described Receives: Diagnostic Test: UBT |
| HpSA | Experimental | Not described Receives: Diagnostic Test: HPSA |
| Standard method | Experimental | Not described Receives: Diagnostic Test: UBT and HPSA |
| Two-stage screening method | Experimental | Not described Receives: Diagnostic Test: Serology (two stage) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rates of H. pylori infection
The positivity rate of H. pylori infection between different study arms, respectively in ITT and PP analysis.
Measured: 2-8 weeks
Secondary outcomes (1)
The compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups
Completion rates of the study (from enrollment to the diagnosis of H. pylori; from enrollment to the treatment of H. pylori infection.
Measured: 2 weeks to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start19 Jul 2022
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H. Pylori InfectionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,403 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387005
- Sponsor's protocol ID
- 202203064RINC
- Status last verified
- Aug 2025
- First submitted
- 28 Apr 2022
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Optimal Screening Strategy for Gastric Cancer Prevention
- ClinicalTrials.gov ID
- NCT05387005
- Acronym / sponsor ID
- 202203064RINC
- Conditions
- H. Pylori Infection
- Keywords
- H. pylori, screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,403 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Detection rate of H. pylori infection
- To compare the compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups.
- To assess the diagnostic accuracy of these tests.
- To verify the compliance(/adherence) and feasibility of this two-stage screening method
- Long-term Outcomes: To assess the risk reduction of gastric cancer
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| UBT | Experimental | Diagnostic Test: UBT |
| HpSA | Experimental | Diagnostic Test: HPSA |
| Standard method | Experimental | Diagnostic Test: UBT and HPSA |
| Two-stage screening method | Experimental | Diagnostic Test: Serology (two stage) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 20 years or older
- Never screened and treated for H. pylori infection
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UBTH. pylori diagnostic test: C13 urea breath test | Diagnostic test | UBT |
| HPSAH. pylori diagnostic test: H. pylori stool antigen test | Diagnostic test | HpSA |
| UBT and HPSAH. pylori diagnostic tests: H. pylori serology test, C13 urea breath test | Diagnostic test | Standard method |
| Serology (two stage)H. pylori diagnostic test: If H. pylori serology is positive, confirmation UBT will be done. | Diagnostic test | Two-stage screening method |
Primary outcome
Detection rates of H. pylori infection
Time frame: 2-8 weeks
The positivity rate of H. pylori infection between different study arms, respectively in ITT and PP analysis.
1 secondary outcome
The compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups
Time frame: 2 weeks to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UBT, HPSA and UBT and HPSA in people with H. Pylori Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jyh-Ming Liou, MD,PhD (886-2-23123456 ext. 63541, jyhmingliou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rates of H. pylori infection (time frame: 2-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.