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Prevention study for Helicobacter Pylori Infections
Official title Multicentric Randomized Study of H. Pylori Eradication and Pepsinogen Testing for Prevention of Gastric Cancer Mortality
ClinicalTrials.gov ID: NCT02047994
What this study is testing
What is Triple therapy?
Triple therapy is an investigational medicine, being studied as a potential treatment for helicobacter pylori infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 64. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Riga, Latvia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 64 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Riga, Latvia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.