Gastric Cancer Risk Factors Associated With EU and CELAC Populations

NCT03957031 | Completed

• 1 other identifier: LEGACY-1
• Study Type: observational
• Target: 1,600
• Locations: 7 countries
• Sites: 8

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

Conditions

Cancer, Gastric

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cases

Patients with a pathological confirmation of GC diagnosis

Control

Patients with confirmed absent of GC

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Subjects \>18 years old, with GC diagnosis. * Subjects \>18 years old to whom a gastroscopy was indicated and confirmed absent of GC

You may qualify if:

• Subjects ≥18 years old.
• Has given and signed the IC to participate in this study.

You may not qualify if:

• 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 ≥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.
• 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.

Sponsors & Collaborators

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

Study Sites (8)

Instituto Alexander Fleming

Buenos Aires, C1426NZ, Argentina

Location

Pontificia Universidad Católica de Chile

Santiago, 8331150, Chile

Location

Instituto Nacional de Cancerología

Mexico City, 01480, Mexico

Location

VU Medical Centre

Amsterdam, 1081, Netherlands

Location

GenPat

Asunción, Paraguay

Location

Institute of Pathology and Immunology of University of Porto

Porto, 4200 135, Portugal

Location

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

Barcelona, 08035, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Related Publications (1)

• 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.

  PMID: 35692051 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 21, 2019
• Study Start: May 31, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

NL (1); ES (2); ME (1); CL (1); PA (1); AR (1); PT (1)