Clinical trial NCT04019808: Gastric Cancer Risk Factors Knowledge in European and Latinamerican Population
Official title: Interventional Study at the Primary and Secondary Levels of Prevention for Knowledge Regarding GC Risk Factors in EU and CELAC Populations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
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: 2019-07-15
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Part 1:

Subjects \>18 years old whom able to answer the questions structured in the survey.

Part 2:

Subjects \>18 years old diagnose from H. pylori infection

Brief summary: This study is divided into two parts:

Part 1: An interventional study, with a pre-post study design to determinate the grade of knowledge of established GC risk factors.

Part 2: An observational study to know impact on prevalence and infection eradication of H. pylori

Detailed description: Part 1: to determinate the grade of knowledge of established GC risk factors and identification of attitudes about, GC screening programs at baseline, prior to the intervention though an educational program.

Part 2: to generate an H. pylori registry, to know its impact on prevalence and infection eradication rate at 6th, 12th, 24th and at Month 36th.

Eligibility criteria: Part A: Educational Intervention Inclusion criteria

* Subjects \>18 years old, from EU and CELAC countries participating in this study.
* Has given and signed the IC to participate in this study. Exclusion criteria
* Subjects who have received some prior preparation (Cancer Gastric Information).
* Subjects who have previous Knowledge in Gastric Cancer (Example, near relatives who have suffered Gastric Cancer

Part B: H. pylori Register Inclusion criteria

* Subjects ≥18 years old diagnose from H. pylori infection and treated at participant sites
* Has given and signed the IC. Exclusion criteria
* Subjects with chronic gastritis without confirmed diagnose of H. pylori infection, pathologically of by urease test.
* Patient's with CG diagnosis (including gastroesophageal junction cancer).

Primary outcomes:
measure: knowledge GC risk factors and symptoms
timeFrame: 3 years
measure: H. pylori prevalence and drug resistance
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
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: Fundación Investigación Clínico 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.