NCT04015466Completed
Advanced GC Multi-omic Characterization in EU and CELAC Populations
Source: ClinicalTrials.gov · Last updated 9 May 2024
Brief summary (registry, in English)
Observational study (cohort type) of advanced GC patients that will be recruited prospectively to study biological factors associated with the disease and relevant clinical outcomes.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 800 (actual)
- First submitted
- 5 Jun 2019
- Start date
- 12 Jun 2019
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04015466
What you commit to
- Study type: Observational
- Participants enrolled: 800
- From 12 Jun 2019 to the primary completion date, 31 Dec 2023
- 8 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to 90 years · Sex: All
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Alexander Fleming Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Pontificia Universidad Catolica de Chile Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Vall d'Hebron Institut d'Oncologia Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Clínico Univeristario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Instituto Nacional de Cancerología de México Coordinator of this site? Confirm its status | México | Mexico | Unknown status |
| VU Medical Centre Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Institute of Pathology and Immunology of University of Porto Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| GenPat Coordinator of this site? Confirm its status | Asunción | Paraguay | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.