Gastric Cancer Risk Factors Knowledge in European and Latinamerican Population (LEGACY-3)

August 18, 2021 updated by: Fundación para la Investigación del Hospital Clínico de Valencia

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

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

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426NZ
        • Recruiting
        • Instituto Alexander Fleming
  • Chile
      • Santiago, Chile, 8331150
        • Recruiting
        • Pontificia Universidad Catolica de Chile
  • Mexico
      • Mexico, Mexico, 01480
        • Recruiting
        • Instituto Nacional de Cancerologia
  • Netherlands
      • Amsterdam, Netherlands, 1081
        • Recruiting
        • VU Medical Centre
  • Paraguay
      • Asunción, Paraguay
        • Recruiting
        • GenPat
  • Portugal
      • Porto, Portugal, 4200 135
        • Recruiting
        • Institute of Pathology and Immunology of University of Porto
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Fundació Privada Institut d'Investigació Oncològica de Vall-Hebron (VHIO)
      • Valencia, Spain, 46010
        • Recruiting
        • Fundación Investigación Clínico de Valencia
        • Contact:
          • Andrés Cervantes, MD PhD
        • Contact:
          • tania Fleitas, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2019

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

June 5, 2019

First Submitted That Met QC Criteria

July 12, 2019

First Posted (Actual)

July 15, 2019

Study Record Updates

Last Update Posted (Actual)

August 24, 2021

Last Update Submitted That Met QC Criteria

August 18, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEGACY-3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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