Gastric Cancer Risk Factors Associated With EU and CELAC Populations

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03957031

Acronym

LEGACY-1

Enrollment

1600

Registered

2019-05-21

Start date

2019-05-31

Completion date

2023-12-31

Last updated

2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Gastric

Keywords

Gastric Cancer, Personalized medicine, Oncology, Solid tumor, Primary Intervention

Brief 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

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: 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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

Inclusion 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. *

Design outcomes

Primary

Measure	Time frame	Description
Exposure to a variety of potential sources of GC risk factors	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.

Countries

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

Outcome results