Gastric Cancer Risk Factors Knowledge in European and Latinamerican Population

Gastric Cancer Clinical Trial

— LEGACY-3  

Official title:

Interventional Study at the Primary and Secondary Levels of Prevention for Knowledge Regarding GC Risk Factors in EU and CELAC Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04019808
• Other study ID #: LEGACY-3
• Status: Completed
• Start date: July 30, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
Argentina	Instituto Alexander Fleming	Buenos Aires
Chile	Pontificia Universidad Católica de Chile	Santiago
Mexico	Instituto Nacional de Cancerología	Mexico
Netherlands	VU Medical Centre	Amsterdam
Paraguay	GenPat	Asunción
Portugal	Institute of Pathology and Immunology of University of Porto	Porto
Spain	Fundació Privada Institut d'Investigació Oncològica de Vall-Hebron (VHIO)	Barcelona
Spain	Fundación Investigación Clínico de Valencia	Valencia

Sponsors (8)

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

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	knowledge GC risk factors and symptoms	Compare the results obtained through a knowledge of CG risk factors by study-specific questionnaire before and after an educational intervention	3 years
Primary	H. pylori prevalence and drug resistance	Generate an H. pylori registry, to know its impact on prevalence and infection eradication rate at months 6th, 12th, 24th and 36th.	3 years