Multicentric Randomized Study of H. Pylori Eradication and Pepsinogen Testing for Prevention of Gastric Cancer Mortality

Launched by INTERNATIONAL AGENCY FOR RESEARCH ON CANCER · Jan 28, 2014

Keywords

ClinConnect Summary

This clinical trial, called the GISTAR study, is looking at whether testing for a bacteria called Helicobacter Pylori (H. Pylori) and treating it can help prevent deaths from gastric cancer. The study aims to enroll 30,000 people aged 40 to 64 who live in areas at high risk for gastric cancer. Participants will be randomly assigned to two groups: one group will receive treatment if they test positive for H. Pylori and will undergo further testing if their pepsinogen levels (a marker related to stomach health) are low. The other group will receive regular healthcare without these additional interventions. Researchers will track the participants for 15 years to see if there’s a difference in gastric cancer mortality between the two groups.

To be eligible for the study, you must be a man or woman aged 40 to 64 and in good health, as determined by a doctor. You should be willing to participate in the study and sign a consent form. Some people may not be eligible, such as those with a history of gastric cancer or certain health conditions. If you join the study, you can expect to undergo tests related to H. Pylori and possibly receive treatment if needed, which could help improve stomach health and reduce the risk of gastric cancer in the future.

Gender

ALL

Eligibility 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