Clinical trial · Interventional
Multicentric Randomized Study of H. Pylori Eradication and Pepsinogen Testing for Prevention of Gastric Cancer Mortality
- 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)
Currently no ideal preventive modalities are available for reducing gastric-cancer caused mortality in organized population-based application. The primary objective of the study is to determine if H.pylori screening followed by eradication of positive subjects and endoscopic follow-up of those with serological evidence of atrophic gastritis reduces mortality from gastric cancer in middle-aged people in high-risk areas. The GISTAR study is a multicenter randomized study of H.pylori eradication and pepsinogen testing for prevention of gastric cancer mortality. Altogether 30.000 individuals aged 40-64 years will be enrolled, providing 90% study power to detect at least 35% reduction in gastric cancer mortality at 15 years of follow-up. Participants will be randomly allocated to one of two groups. In the active investigation/management group those positive for H.pylori will be offered eradication therapy and individuals with decreased pepsinogen I/II ratio will be invited for endoscopy. The control group will receive standard health care. The primary endpoint for this trial will be the mortality difference from gastric cancer between the two groups at 15 years or when enough cases accumulate to demonstrate a statistical difference. The study is expected to provide valuable information on the utility for reduction in gastric cancer mortality of: 1) H.pylori eradication in adults on a population-basis, including subjects who may already have pre-malignant lesions; and 2) pepsinogen testing in screening settings. A pilot study of 3,455 individuals prior to the main trial was conducted from October 2013 to December 2016.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atrophic Gastritis | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Helicobacter Pylori Infections | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Triple therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1:Triple therapy
- description
- Among those assigned to Group 1, participants who are Helicobacter pylori positive will receive Triple therapy and/or upper endoscopy. Participants with serological evidence of atrophic gastritis will undergo upper endoscopy and further endoscopic follow-up. H. pylori positive individuals will be offered Helicobacter pylori eradication as appropriate, independently of the pepsinogen results. From subjects in this group, breath samples will also be collected for volatile markers study. In addition, fecal occult blood test (FOBT) will be offered to this group as a benefit to participate in the study.
- interventionNames
- Drug: Triple therapy
- type
- NO_INTERVENTION
- label
- Group 2:No intervention
- description
- Those who assigned to Group 2 will receive no intervention and will be offered FOBT as a benefit of study participation. Any participants who show positive FOBT will be referred to colonoscopy. This will be the benefit to this group together with initial medical evaluation at the time of inclusion. During the follow-up period this group will be offered to consult a specialist when required due to clinical symptoms.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women aged 40-64 at the time of signing the consent form * Willingness to get involved in the study irrespective in which of the study arms (after detailed information on the potential benefits and risks that this study may confer) * The person has signed a consent form (including the acceptance of transporting the samples over the borders, as appropriate) * To be in good health, as determined by a physical examination and history performed by a study physician at enrolment Exclusion Criteria: * Personal history of gastric cancer (prevalent gastric cancer cases will not be revealed at the time of inclusion, and therefore will be included) * Gastric resections due to benign disease (ulcer suturing and vagotomy are accepted) * H. pylori eradication therapy within 12 months prior to inclusion (irrespective of the treatment result) * Presence of alarm symptoms for digestive or any other diseases (detailed in the questionnaire or during the physician evaluation) * Pathological findings at physical investigation suggestive for a serious organic disease (physician evaluation) * Serious co-morbid condition with life expectancy less than 5 years (physician evaluation) * Factors otherwise limiting the participation according to the protocol conditions (problems of mobility, etc.) * Serious psychological conditions/psychiatric disease limiting the possibilities to understand the requirements for diagnostic and/or medical interventions (physician evaluation) * Low expectations on the compliance for the diagnostic work-up or treatment (physician evaluation) * Expected loss for the follow-up (e.g. lack of communication possibilities and data entry in the registries, expected travel abroad, etc.) (physician evaluation) * Signed consent form is not available
References
Publications (2)
- DERIVEDLeja M, Cine E, Polaka I, Daugule I, Murillo R, Parshutin S, Razuka-Ebela D, Rotberga L, Anarkulova L, Krike P, Santare D, Tzivian L, Herrero R, Park JY. Factors influencing participation in preventive interventions for gastric cancer: the results from the GISTAR study. Eur J Cancer Prev. 2022 Mar 1;31(2):128-136. doi: 10.1097/CEJ.0000000000000682. PMID 34519690
- DERIVEDLeja M, Park JY, Murillo R, Liepniece-Karele I, Isajevs S, Kikuste I, Rudzite D, Krike P, Parshutin S, Polaka I, Kirsners A, Santare D, Folkmanis V, Daugule I, Plummer M, Herrero R. Multicentric randomised study of Helicobacter pylori eradication and pepsinogen testing for prevention of gastric cancer mortality: the GISTAR study. BMJ Open. 2017 Aug 11;7(8):e016999. doi: 10.1136/bmjopen-2017-016999. PMID 28801429