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:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT04015466
Eligibility Criteria:
Cases:
* Inclusion criteria:
* Subjects ≥18 years old.
* GC diagnosis stages III and IV (including gastroesophageal junction cancer) and/or a gastroscopy indication due to the high diagnostic suspicion of GC as part of the study of his disease.
* Has given and signed the IC to participate in this study.
* Exclusion criteria:
• Patients diagnosed with GC early disease (stage I and II) suitable for resectable strategy.
* Withdrawal criteria:
* Patients initially recruited with high suspicion of GC diagnosis but not confirmed by the pathological report.
Controls:
* Inclusion criteria (only for microbiome analysis):
* Subjects ≥18 years old.
* Subjects to whom a gastroscopy is indicated within clinical care and is confirmed absent of GC in the same centres will be matched in age (+/- 10 years), gender and pertaining from the same region of the GC case.
* Has given and signed the IC to participate in this study.
* Exclusion criteria:
* Subjects from a different geographic area from the cases.
* Patients with high suspicion of GC.
* Patients with previous histopathologic diagnosis of peptic (gastric or duodenal) ulcer disease and/or atrophy or intestinal metaplasia.
* Patients that have received antimicrobials during the 4 weeks period prior to the endoscopy.
* Patients that have received proton pump inhibitors or H2-receptor antagonists, at least 2 weeks prior to the endoscopy
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04015466
Study Brief:
Protocol Section:
NCT04015466