Gastric CancerLEGACY-3NCT04019808
Gastric Cancer Risk Factors Knowledge in European and Latinamerican Population
An observational study of Gastric Cancer, run by Fundación para la Investigación del Hospital Clínico de Valencia at 8 sites in 7 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastric Cancer
- How many people
- 800 participants
- Where
- 8 sitesin 7 countries
- Study dates
- 30 Jul 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
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
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).
Trial locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
Spain2 sites
Fundació Privada Institut d'Investigació Oncològica de Vall-Hebron (VHIO)
Barcelona, 08035
Fundación Investigación Clínico de Valencia
Valencia, 46010
Portugal1 site
Institute of Pathology and Immunology of University of Porto
Porto, 4200 135
About this study
Official title: 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
Read the 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.
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, Personalized medicine, Oncology, Solid tumor, Primary Intervention
- Medical subject headings
- Stomach Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start30 Jul 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Cancerologia de Mexico, Amsterdam UMC, location VUmc, 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019808
- Sponsor's protocol ID
- LEGACY-3
- Acronym
- LEGACY-3
- Status last verified
- May 2024
- First submitted
- 5 Jun 2019
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39939517van 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.
PubMed 35692051
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Study at the Primary and Secondary Levels of Prevention for Knowledge Regarding GC Risk Factors in EU and CELAC Populations
- ClinicalTrials.gov ID
- NCT04019808
- Acronym / sponsor ID
- LEGACY-3 / LEGACY-3
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, Personalized medicine, Oncology, Solid tumor, Primary Intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Collaborators
- Instituto Nacional de Cancerologia de Mexico, Amsterdam UMC, location VUmc, 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
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 15 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Derived from this study: PubMed 39939517Carbonell-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.
- Derived from this study: PubMed 35692051van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Fundación para la Investigación del Hospital Clínico de Valencia at 8 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, Argentina, Chile, Mexico, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knowledge GC risk factors and symptoms (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04019808, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.