Preventing gastric cancer mortality through H. Pylori eradication and pepsinogen testing
Multicentric Randomized Study of H. Pylori Eradication and Pepsinogen Testing for Prevention of Gastric Cancer Mortality
This study is testing if treating Helicobacter pylori infections and monitoring stomach health can help lower the risk of gastric cancer in middle-aged people living in high-risk areas.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30000 (estimated) |
| Ages | 40 Years to 64 Years |
| Sex | All |
| Sponsor | International Agency for Research on Cancer Academic / other |
| Locations | 1 site (Riga) |
| Trial ID | NCT02047994 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether screening for Helicobacter pylori followed by eradication treatment and endoscopic follow-up for individuals with atrophic gastritis can reduce gastric cancer mortality in middle-aged populations in high-risk areas. A total of 30,000 participants aged 40-64 will be enrolled and randomly assigned to receive either active management or standard care. The study will follow participants for 15 years to assess the effectiveness of these interventions in reducing gastric cancer mortality. The trial is being conducted in Latvia, Belarus, and Russia, where the burden of gastric cancer is significant.
Who should consider this trial
Good fit: Ideal candidates for this study are men and women aged 40-64 who are willing to participate and are in good health.
Not a fit: Patients with a personal history of gastric cancer or recent H. pylori eradication therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce mortality rates from gastric cancer in high-risk populations.
How similar studies have performed: Previous studies have suggested a link between H. pylori eradication and reduced gastric cancer risk, but this specific approach is novel and has not been extensively tested in organized screening settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Riga
- Institute of Clinical and Preventive Medicine, University of Latvia — Riga, Latvia (Recruiting)
Study contacts
- Principal investigator: Marcis Leja, MD, PhD — Professor, Institute of Clinical and Preventive Medicine, University of Latvia
- Study coordinator: Marcis Leja, MD, PhD
- Email: marcis.leja@lu.lv
- Phone: +37 1 29 49 75 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.