NCT04019808

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 observational study to know impact on prevalence and infection eradication of H. pylori

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
7 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 15, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

July 30, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

4.4 years

First QC Date

June 5, 2019

Last Update Submit

May 8, 2024

Conditions

Keywords

Gastric CancerPersonalized medicineOncologySolid tumorPrimary Intervention

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Subjects \>18 years old, from EU and CELAC countries participating in this study.

You may not qualify if:

  • 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
  • Subjects ≥18 years old diagnose from H. pylori infection and treated at participant sites
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Instituto Alexander Fleming

Buenos Aires, C1426NZ, Argentina

Location

Pontificia Universidad Católica de Chile

Santiago, 8331150, Chile

Location

Instituto Nacional de Cancerología

México, 01480, Mexico

Location

VU Medical Centre

Amsterdam, 1081, Netherlands

Location

GenPat

Asunción, Paraguay

Location

Institute of Pathology and Immunology of University of Porto

Porto, 4200 135, Portugal

Location

Fundació Privada Institut d'Investigació Oncològica de Vall-Hebron (VHIO)

Barcelona, 08035, Spain

Location

Fundación Investigación Clínico de Valencia

Valencia, 46010, Spain

Location

Related Publications (2)

  • Carbonell-Asins JA, Jimenez-Marti E, Romero S, Garcia E, Miralles-Marco A, Lopez B, Huerta M, Caballero C, Boggino H, Gauna C, Acevedo-Funes OB, Nunez GB, Cespedes-Cardozo CM, Fernandez-Figueroa EA, Ortiz-Olvera N, Ruiz-Garcia E, Carneiro F, Barros R, Figueiredo C, Ferreira RM, Groen-van Schooten TS, van Santvliet D, Derks S, Luca R, Alsina M, Riquelme A, Cervantes A, Fleitas T. Implementation of an Educational Intervention for Gastric Cancer Awareness in the General Population in CELAC and Europe: A Strategy Proposed by the LEGACy Consortium. J Cancer Educ. 2025 Oct;40(5):804-811. doi: 10.1007/s13187-025-02578-2. Epub 2025 Feb 13.

  • van Schooten TS, Derks S, Jimenez-Marti E, Carneiro F, Figueiredo C, Ruiz E, Alsina M, Molero C, Garrido M, Riquelme A, Caballero C, Lezcano E, O'Connor JM, Esteso F, Farres J, Mas JM, Lordick F, Vogt J, Cardone A, Girvalaki C, Cervantes A, Fleitas T; members of LEGACy consortium. The LEGACy study: a European and Latin American consortium to identify risk factors and molecular phenotypes in gastric cancer to improve prevention strategies and personalized clinical decision making globally. BMC Cancer. 2022 Jun 13;22(1):646. doi: 10.1186/s12885-022-09689-9.

MeSH Terms

Conditions

Stomach NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2019

First Posted

July 15, 2019

Study Start

July 30, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 9, 2024

Record last verified: 2024-05

Locations