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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
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

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto Alexander Fleming
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Pontificia Universidad Catolica de Chile
Coordinator of this site? Confirm its status
SantiagoChileUnknown status
Vall d'Hebron Institut d'Oncologia
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
Hospital Clínico Univeristario de Valencia
Coordinator of this site? Confirm its status
ValenciaSpainUnknown status
Instituto Nacional de Cancerología de México
Coordinator of this site? Confirm its status
MéxicoMexicoUnknown status
VU Medical Centre
Coordinator of this site? Confirm its status
AmsterdamNetherlandsUnknown status
Institute of Pathology and Immunology of University of Porto
Coordinator of this site? Confirm its status
PortoPortugalUnknown status
GenPat
Coordinator of this site? Confirm its status
AsunciónParaguayUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.