Multicentric Randomized Study of H. Pylori Eradication and Pepsinogen Testing for Prevention of G… (NCT02047994) | Clinical Trial Compass
RecruitingPhase 4
Multicentric Randomized Study of H. Pylori Eradication and Pepsinogen Testing for Prevention of Gastric Cancer Mortality
Latvia30,000 participantsStarted 2013-03
Plain-language summary
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.
Who can participate
Age range
40 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 evaluati…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gastric cancer mortality
Timeframe: 15 years
Trial details
NCT IDNCT02047994
SponsorInternational Agency for Research on Cancer