Clinical trial NCT03957031: Gastric Cancer Risk Factors Associated With EU and CELAC Populations
Official title: Gastric Cancer Risk Factors Associated With EU and CELAC Populations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer, Gastric
Keywords: Gastric Cancer
Personalized medicine
Oncology
Solid tumor
Primary Intervention
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
Collaborators: name: Instituto Nacional de Cancerologia de Mexico
name: Amsterdam UMC, location VUmc
name: Pontificia Universidad Catolica de Chile
name: Vall d'Hebron Institute of Oncology
name: INSTITUTO ALEXANDER FLEMING
name: Hospital Central del IPS
name: IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto
First posted: 2019-05-21
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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

Eligibility 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.

Primary outcomes:
measure: Exposure to a variety of potential sources of GC risk factors
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Instituto Alexander Fleming
city: Santiago
country: Chile
facility: Pontificia Universidad Católica de Chile
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cancerología
city: Amsterdam
country: Netherlands
facility: VU Medical Centre
city: Asunción
country: Paraguay
facility: GenPat
city: Porto
country: Portugal
facility: Institute of Pathology and Immunology of University of Porto
city: Barcelona
country: Spain
facility: Fundació Privada Institut d'Investigació Oncològica de Vall-Hebron (VHIO)
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
Study officials:
References:
citation: 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.