Gastric Cancer Risk Factors Associated With EU and CELAC Populations (LEGACY-1)
May 8, 2024 updated by: Fundación para la Investigación del Hospital Clínico de Valencia
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
Study Overview
Status
Completed
Conditions
Detailed Description
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
Study Type
Observational
Enrollment (Actual)
1600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina, C1426NZ
- Instituto Alexander Fleming
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Santiago, Chile, 8331150
- Pontificia Universidad Católica de Chile
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Mexico City, Mexico, 01480
- Instituto Nacional de Cancerologia
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Amsterdam, Netherlands, 1081
- VU Medical Centre
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Asunción, Paraguay
- GenPat
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Porto, Portugal, 4200 135
- Institute of Pathology and Immunology of University of Porto
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Barcelona, Spain, 08035
- Fundació Privada Institut d'Investigació Oncològica de Vall-Hebron (VHIO)
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Valencia, Spain, 46010
- Hospital Clínico Universitario de Valencia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
- Subjects >18 years old, with GC diagnosis.
- Subjects >18 years old to whom a gastroscopy was indicated and confirmed absent of GC
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cases
Patients with a pathological confirmation of GC diagnosis
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Control
Patients with confirmed absent of GC
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Exposure to a variety of potential sources of GC risk factors
Time Frame: 3 years
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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.
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3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 31, 2019
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
May 17, 2019
First Submitted That Met QC Criteria
May 20, 2019
First Posted (Actual)
May 21, 2019
Study Record Updates
Last Update Posted (Actual)
May 9, 2024
Last Update Submitted That Met QC Criteria
May 8, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LEGACY-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.