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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03957031
Other study ID # LEGACY-1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 31, 2019
Est. completion date December 31, 2023

Study information

Verified date May 2024
Source Fundación para la Investigación del Hospital Clínico de Valencia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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: 1. 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. 2. Identify clinical, demographic, and epidemiological differences among the populations participating in this study


Recruitment information / eligibility

Status Completed
Enrollment 1600
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Argentina Instituto Alexander Fleming Buenos Aires
Chile Pontificia Universidad Católica de Chile Santiago
Mexico Instituto Nacional de Cancerología Mexico City
Netherlands VU Medical Centre Amsterdam
Paraguay GenPat Asunción
Portugal Institute of Pathology and Immunology of University of Porto Porto
Spain Fundació Privada Institut d'Investigació Oncològica de Vall-Hebron (VHIO) Barcelona
Spain Hospital Clínico Universitario de Valencia Valencia

Sponsors (8)

Lead Sponsor Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia Amsterdam UMC, location VUmc, Hospital Central del IPS, INSTITUTO ALEXANDER FLEMING, Instituto Nacional de Cancerologia de Mexico, IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto, Pontificia Universidad Catolica de Chile, Vall d'Hebron Institute of Oncology

Countries where clinical trial is conducted

Argentina,  Chile,  Mexico,  Netherlands,  Paraguay,  Portugal,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Exposure to a variety of potential sources of GC risk factors 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. 3 years
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