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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)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (8 locations)

    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