Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT02047994
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
64 Years
Study:
NCT02047994
Study Brief:
Protocol Section:
NCT02047994