Status:
COMPLETED
Advanced GC Multi-omic Characterization in EU and CELAC Populations
Lead Sponsor:
Fundación para la Investigación del Hospital Clínico de Valencia
Collaborating Sponsors:
Instituto Nacional de Cancerologia de Mexico
Amsterdam UMC, location VUmc
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-90 years
Brief Summary
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.
Detailed Description
Despite of multiple attempts to improve treatment in recent decades, none strategies has improved prognosis in locally advanced stage III and IV GC. A therapeutic approach to GC based on current histo...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 12 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT04015466
Start Date
June 12 2019
End Date
December 31 2023
Last Update
May 9 2024
Active Locations (8)
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1
Instituto Alexander Fleming
Buenos Aires, Argentina, C1426ANZ
2
Pontificia Universidad Católica de Chile
Santiago, Chile, 8331150
3
Instituto Nacional de Cancerología de México
México, Mexico, 01480
4
VU Medical Centre
Amsterdam, Netherlands, 1081