Gastric Cancer Risk Factors Associated With EU and CELAC Populations

NCT ID: NCT03957031

Last Updated: 2024-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-31

Study Completion Date

2023-12-31

Brief Summary

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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

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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

Conditions

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Cancer, Gastric

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cases

Patients with a pathological confirmation of GC diagnosis

No interventions assigned to this group

Control

Patients with confirmed absent of GC

No interventions assigned to this group

Eligibility Criteria

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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.

* 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

* 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


* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Nacional de Cancerologia de Mexico

OTHER

Sponsor Role collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role collaborator

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role collaborator

Vall d'Hebron Institute of Oncology

OTHER

Sponsor Role collaborator

INSTITUTO ALEXANDER FLEMING

UNKNOWN

Sponsor Role collaborator

Hospital Central del IPS

OTHER

Sponsor Role collaborator

IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto

OTHER

Sponsor Role collaborator

Fundación para la Investigación del Hospital Clínico de Valencia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Instituto Alexander Fleming

Buenos Aires, , Argentina

Site Status

Pontificia Universidad Católica de Chile

Santiago, , Chile

Site Status

Instituto Nacional de Cancerología

Mexico City, , Mexico

Site Status

VU Medical Centre

Amsterdam, , Netherlands

Site Status

GenPat

Asunción, , Paraguay

Site Status

Institute of Pathology and Immunology of University of Porto

Porto, , Portugal

Site Status

Fundació Privada Institut d'Investigació Oncològica de Vall-Hebron (VHIO)

Barcelona, , Spain

Site Status

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Site Status

Countries

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Argentina Chile Mexico Netherlands Paraguay Portugal Spain

References

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van Schooten TS, Derks S, Jimenez-Marti E, Carneiro F, Figueiredo C, Ruiz E, Alsina M, Molero C, Garrido M, Riquelme A, Caballero C, Lezcano E, O'Connor JM, Esteso F, Farres J, Mas JM, Lordick F, Vogt J, Cardone A, Girvalaki C, Cervantes A, Fleitas T; members of LEGACy consortium. The LEGACy study: a European and Latin American consortium to identify risk factors and molecular phenotypes in gastric cancer to improve prevention strategies and personalized clinical decision making globally. BMC Cancer. 2022 Jun 13;22(1):646. doi: 10.1186/s12885-022-09689-9.

Reference Type DERIVED
PMID: 35692051 (View on PubMed)

Other Identifiers

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LEGACY-1

Identifier Type: -

Identifier Source: org_study_id

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