Gastric Cancer Risk Factors Associated With EU and CELAC Populations (LEGACY-1)

Fundación para la Investigación del Hospital Clínico de Valencia

Status

Completed

Conditions

Cancer, Gastric

Study type

Observational

Funder types

Other

Identifiers

NCT03957031

LEGACY-1

Details and patient eligibility

About

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

Full 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

Enrollment

1,600 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.