Gastric Cancer Risk Factors Associated With EU and CELAC Populations

Cancer, Gastric Clinical Trial

— LEGACY-1  

Official title:

Gastric Cancer Risk Factors Associated With EU and CELAC Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03957031
• Other study ID #: LEGACY-1
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Cancer, Gastric
• Stomach Neoplasms

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