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出境医 / 临床实验 / Gastric Cancer Risk Factors Associated With EU and CELAC Populations (LEGACY-1)

Gastric Cancer Risk Factors Associated With EU and CELAC Populations (LEGACY-1)

Study Description
Brief Summary:
The study uses a case-control design that examines the differences in types of exposures between cases defined with a pathological confirmation of GC diagnosis, and controls, defined as patients to whom a gastroscopy was indicated and confirmed absent of GC i

Condition or disease
Cancer, Gastric

Detailed Description:

GC is associated to several known risk factors. Epidemiological and molecular features of GCs can vary widely. The reasons behind these differences are multiple and complex and may include genetic susceptibility, strains of the bacterium Helicobacter pylori (H. pylori), Epstein Barr virus infection, dietary factors and others. These factors can influence GC outcomes. There is little knowledge regarding how these risk factors are associated with GC in CELAC and EU populations.

The primary objectives of this study are to:

  1. Identify risk factors associated with GC in the CELAC and EU populations participating in this study including Argentina, Spain, Mexico, Netherlands, Chile, Portugal and Paraguay.
  2. Identify clinical, demographic, and epidemiological differences among the populations participating in this study
Study Design
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Study Type : Observational
Estimated Enrollment : 1600 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Gastric Cancer Risk Factors Associated With EU and CELAC Populations
Actual Study Start Date : May 31, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Group/Cohort
Cases
Patients with a pathological confirmation of GC diagnosis
Control
Patients with confirmed absent of GC
Outcome Measures
Primary Outcome Measures :
  1. Exposure to a variety of potential sources of GC risk factors [ Time Frame: 3 years ]
    The ratio of the odds of exposure vs. odds of no exposure to a variety of potential sources of GC risk factors in cases vs. controls.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  • Subjects >18 years old, with GC diagnosis.
  • Subjects >18 years old to whom a gastroscopy was indicated and confirmed absent of GC
Criteria

Cases

  • Inclusion criteria

    • Subjects ≥18 years old.
    • GC diagnosis (including gastroesophageal junction cancer) from IPATIMUP, INCAN, VUMC, PUC, VHIO, IAF, INCLIVA and GENPAT centres, in the last six months before his/her inclusion in the study.
    • Has given and signed the IC to participate in this study.

  • Exclusion criteria:

    • Patients diagnosed with GC (including gastroesophageal junction cancer) from other centres/ countries not participating in this proposal.
    • Patients with suspected with GC diagnosis but not confirmed by the pathological report.

Controls

  • Inclusion criteria

    • Subjects ≥18 years old.
    • Subjects to whom a gastroscopy was indicated in its medical care and confirmed absent of GC in the same centres will be matched in age (+/- 10 years), gender and pertaining from the same region of the GC case. Thus, to match our GC cases same number of controls is expected to be recruited.
    • Has given and signed the IC to participate in this study.

  • Exclusion criteria:

    • Subjects from a different geographic area from the cases.
    • Patients with high suspicion of GC (including gastroesophageal junction cancer) or previous personal history known of document chronic gastritis diagnosed by endoscopy and confirmed by histology.
Contacts and Locations

Contacts
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Contact: Andrés Cervantes, MD + 34 961973543 andres.cervantes@uv.es
Contact: Tania Fleitas, MD + 34 961973543 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
Contact: Marcelo Garrido, MD PhD         
Mexico
Instituto Nacional de Cancerología Recruiting
Mexico City, Mexico, 01480
Contact: Erika Ruiz, MD PhD         
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         
Hospital Clínico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Contact: Andres Cervantes, Professor         
Contact: Tania Fleitas, 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 May 17, 2019
First Posted Date May 21, 2019
Last Update Posted Date July 22, 2020
Actual Study Start Date May 31, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 20, 2019) 		Exposure to a variety of potential sources of GC risk factors [ Time Frame: 3 years ]
The ratio of the odds of exposure vs. odds of no exposure to a variety of potential sources of GC risk factors in cases vs. controls.
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 Associated With EU and CELAC Populations
Official Title Gastric Cancer Risk Factors Associated With EU and CELAC Populations
Brief Summary The study uses a case-control design that examines the differences in types of exposures between cases defined with a pathological confirmation of GC diagnosis, and controls, defined as patients to whom a gastroscopy was indicated and confirmed absent of GC i
Detailed Description

GC is associated to several known risk factors. Epidemiological and molecular features of GCs can vary widely. The reasons behind these differences are multiple and complex and may include genetic susceptibility, strains of the bacterium Helicobacter pylori (H. pylori), Epstein Barr virus infection, dietary factors and others. These factors can influence GC outcomes. There is little knowledge regarding how these risk factors are associated with GC in CELAC and EU populations.

The primary objectives of this study are to:

  1. Identify risk factors associated with GC in the CELAC and EU populations participating in this study including Argentina, Spain, Mexico, Netherlands, Chile, Portugal and Paraguay.
  2. Identify clinical, demographic, and epidemiological differences among the populations participating in this study
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population
  • Subjects >18 years old, with GC diagnosis.
  • Subjects >18 years old to whom a gastroscopy was indicated and confirmed absent of GC
Condition Cancer, Gastric
Intervention Not Provided
Study Groups/Cohorts
  • Cases
    Patients with a pathological confirmation of GC diagnosis
  • Control
    Patients with confirmed absent of GC
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: May 20, 2019) 		1600
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

Cases

  • Inclusion criteria

    • Subjects ≥18 years old.
    • GC diagnosis (including gastroesophageal junction cancer) from IPATIMUP, INCAN, VUMC, PUC, VHIO, IAF, INCLIVA and GENPAT centres, in the last six months before his/her inclusion in the study.
    • Has given and signed the IC to participate in this study.

  • Exclusion criteria:

    • Patients diagnosed with GC (including gastroesophageal junction cancer) from other centres/ countries not participating in this proposal.
    • Patients with suspected with GC diagnosis but not confirmed by the pathological report.

Controls

  • Inclusion criteria

    • Subjects ≥18 years old.
    • Subjects to whom a gastroscopy was indicated in its medical care and confirmed absent of GC in the same centres will be matched in age (+/- 10 years), gender and pertaining from the same region of the GC case. Thus, to match our GC cases same number of controls is expected to be recruited.
    • Has given and signed the IC to participate in this study.

  • Exclusion criteria:

    • Subjects from a different geographic area from the cases.
    • Patients with high suspicion of GC (including gastroesophageal junction cancer) or previous personal history known of document chronic gastritis diagnosed by endoscopy and confirmed by histology.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Andrés Cervantes, MD + 34 961973543 andres.cervantes@uv.es
Contact: Tania Fleitas, MD + 34 961973543 tfleitask@gmail.com
Listed Location Countries Argentina,   Chile,   Mexico,   Netherlands,   Paraguay,   Portugal,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03957031
Other Study ID Numbers LEGACY-1
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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