NCT05387005 Screening Strategy for Gastric Cancer Prevention
| NCT ID | NCT05387005 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Taiwan University Hospital |
| Condition | H. Pylori Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 4,403 participants |
| Start Date | 2022-07-19 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 4,403 participants in total. It began in 2022-07-19 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05387005 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying H. Pylori Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05387005 currently recruiting?
Yes, NCT05387005 is actively recruiting participants. Contact the research team at jyhmingliou@gmail.com for enrollment information.
Where is the NCT05387005 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT05387005 clinical trial?
NCT05387005 is sponsored by National Taiwan University Hospital. The trial plans to enroll 4,403 participants.