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OpenTrials
Completed

NCT Number: NCT04019808

Gastric Cancer Risk Factors Knowledge in European and Latinamerican Population

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

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Alexander Fleming, Buenos Aires, Argentina

Loading trial locations.

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. knowledge GC risk factors and symptoms

    Time frame: 3 years

    Compare the results obtained through a knowledge of CG risk factors by study-specific questionnaire before and after an educational intervention

  2. H. pylori prevalence and drug resistance

    Time frame: 3 years

    Generate an H. pylori registry, to know its impact on prevalence and infection eradication rate at months 6th, 12th, 24th and 36th.

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Other

Collaborators

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

Registry information

Official study title

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

Acronym: LEGACY-3

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 15, 2019
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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