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出境医 / 临床实验 / Gastric Cancer Risk Factors Knowledge in European and Latinoamerican Population (LEGACY-3)

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

Study Description
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 observacitonal study to know impact on prevalence and infection eradication of H. pylori


Condition or disease
Gastric Cancer

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 Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Interventional Study at the Primary and Secondary Levels of Prevention for Knowledge Regarding GC Risk Factors in EU and CELAC Populations
Actual Study Start Date : July 30, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes 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

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).
Contacts and Locations

Contacts
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Contact: Andrés Cervantes, MD 0034961973543 andres.cervantes@uv.es
Contact: Tania Fleitas, MD 0034961973543 tfleitask@gmail.com

Locations
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Argentina
Instituto Alexander Fleming Recruiting
Buenos Aires, Argentina, C1426NZ
Contact: Juan Manuel O'Connor, MD PhD         
Chile
Pontificia Universidad Católica de Chile Recruiting
Santiago, Chile, 8331150
Mexico
Instituto Nacional de Cancerología Recruiting
Mexico, Mexico, 01480
Netherlands
VU Medical Centre Recruiting
Amsterdam, Netherlands, 1081
Contact: Sarah Derks, MD PhD         
Paraguay
GenPat Recruiting
Asunción, Paraguay
Contact: Carmelo Caballero, MD PhD         
Portugal
Institute of Pathology and Immunology of University of Porto Recruiting
Porto, Portugal, 4200 135
Contact: Fátima Carneiro, MD PhD         
Spain
Fundació Privada Institut d'Investigació Oncològica de Vall-Hebron (VHIO) Recruiting
Barcelona, Spain, 08035
Contact: Maria Alsina, MD PhD         
Fundación Investigación Clínico de Valencia Recruiting
Valencia, Spain, 46010
Contact: Andrés Cervantes, MD PhD         
Contact: tania Fleitas, MD PhD         
Sponsors and Collaborators
Fundación para la Investigación del Hospital Clínico de Valencia
Instituto Nacional de Cancerologia de Mexico
VU University Medical Center
Pontificia Universidad Catolica de Chile
Vall d'Hebron Institute of Oncology
INSTITUTO ALEXANDER FLEMING
Hospital Central del IPS
IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto
Tracking Information
First Submitted Date June 5, 2019
First Posted Date July 15, 2019
Last Update Posted Date July 22, 2020
Actual Study Start Date July 30, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 12, 2019)
  • 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
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Gastric Cancer Risk Factors Knowledge in European and Latinoamerican Population
Official Title Interventional Study at the Primary and Secondary Levels of Prevention for Knowledge Regarding GC Risk Factors in EU and CELAC Populations
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 observacitonal 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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Gastric Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 12, 2019) 		800
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Andrés Cervantes, MD 0034961973543 andres.cervantes@uv.es
Contact: Tania Fleitas, MD 0034961973543 tfleitask@gmail.com
Listed Location Countries Argentina,   Chile,   Mexico,   Netherlands,   Paraguay,   Portugal,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT04019808
Other Study ID Numbers LEGACY-3
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Fundación para la Investigación del Hospital Clínico de Valencia
Study Sponsor Fundación para la Investigación del Hospital Clínico de Valencia
Collaborators
  • Instituto Nacional de Cancerologia de Mexico
  • VU University Medical Center
  • Pontificia Universidad Catolica de Chile
  • Vall d'Hebron Institute of Oncology
  • INSTITUTO ALEXANDER FLEMING
  • Hospital Central del IPS
  • IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto
Investigators Not Provided
PRS Account Fundación para la Investigación del Hospital Clínico de Valencia
Verification Date July 2020

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