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OpenTrials
Completed

NCT Number: NCT03957031

Gastric Cancer Risk Factors Associated With EU and CELAC Populations

The study uses a case-control design that examines the differences in types of exposures between cases defined with a pathological confirmation of GC diagnosis, and controls, defined as patients to whom a gastroscopy was indicated and confirmed absent of GC i

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Alexander Fleming, Buenos Aires, Argentina

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About this study

GC is associated to several known risk factors. Epidemiological and molecular features of GCs can vary widely. The reasons behind these differences are multiple and complex and may include genetic susceptibility, strains of the bacterium Helicobacter pylori (H. pylori), Epstein Barr virus infection, dietary factors and others. These factors can influence GC outcomes. There is little knowledge regarding how these risk factors are associated with GC in CELAC and EU populations.

The primary objectives of this study are to:

  • Identify risk factors associated with GC in the CELAC and EU populations participating in this study including Argentina, Spain, Mexico, Netherlands, Chile, Portugal and Paraguay.
  • Identify clinical, demographic, and epidemiological differences among the populations participating in this study

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Cases

  • Inclusion criteria
  • Subjects ≥18 years old.
  • GC diagnosis (including gastroesophageal junction cancer) from IPATIMUP, INCAN, VUMC, PUC, VHIO, IAF, INCLIVA and GENPAT centres, in the last six months before his/her inclusion in the study.
  • Has given and signed the IC to participate in this study.
  • Exclusion criteria:
  • Patients diagnosed with GC (including gastroesophageal junction cancer) from other centres/ countries not participating in this proposal.
  • Patients with suspected with GC diagnosis but not confirmed by the pathological report.

Controls

  • Inclusion criteria
  • Subjects ≥18 years old.
  • Subjects to whom a gastroscopy was indicated in its medical care and 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. Thus, to match our GC cases same number of controls is expected to be recruited.
  • 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 (including gastroesophageal junction cancer) or previous personal history known of document chronic gastritis diagnosed by endoscopy and confirmed by histology.

Treatment and study plan

Primary outcomes

  1. Exposure to a variety of potential sources of GC risk factors

    Time frame: 3 years

    The ratio of the odds of exposure vs. odds of no exposure to a variety of potential sources of GC risk factors in cases vs. controls.

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Other

Collaborators

  • Amsterdam UMC, location VUmc
  • Hospital Central del IPS
  • INSTITUTO ALEXANDER FLEMING
  • IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto
  • Instituto Nacional de Cancerologia de Mexico
  • Pontificia Universidad Catolica de Chile
  • Vall d'Hebron Institute of Oncology

Registry information

Acronym: LEGACY-1

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 21, 2019
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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