Clinical trial · Interventional
Screening Strategy for Gastric Cancer Prevention
Identification of the Optimal Screening Strategy for Gastric Cancer Prevention
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| H. Pylori Infection | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPSA | Diagnostic Test | — | UNRESOLVED |
| Serology (two stage) | Diagnostic Test | — | UNRESOLVED |
| UBT | Diagnostic Test | — | UNRESOLVED |
| UBT and HPSA | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- UBT
- interventionNames
- Diagnostic Test: UBT
- type
- EXPERIMENTAL
- label
- HpSA
- interventionNames
- Diagnostic Test: HPSA
- type
- EXPERIMENTAL
- label
- Standard method
- interventionNames
- Diagnostic Test: UBT and HPSA
- type
- EXPERIMENTAL
- label
- Two-stage screening method
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available