Preventing gastric cancer mortality through H. Pylori eradication and pepsinogen testing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  Recruiting Stanford University · Stanford, California · NCT04191551

• Breath testing for gastric cancer screening

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  Recruiting at 3 sites University of Latvia · São Paulo and 4 other locations · NCT04022109

• Dual vonoprazan and amoxicillin therapy for Helicobacter pylori infection in Uruguay

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.