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CompletedNCT04019808LEGACY-3Updated May 9, 2024

Gastric Cancer Risk Factors Knowledge in European and Latinamerican Population

An observational study in Gastric Cancer, sponsored by Fundación para la Investigación del Hospital Clínico de Valencia. Completed at 8 sites in 7 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-05-09.

Sponsored by Fundación para la Investigación del Hospital Clínico de Valencia · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
800
Ages
18 Years to 90 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Gastric Cancer

Keywords

  • Gastric Cancer
  • Personalized medicine
  • Oncology
  • Solid tumor
  • Primary Intervention
03

In context

Stomach Neoplasms

3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.

This study's enrollment of 800 is above the median of 278 across 790 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia is the lead sponsor of 73 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
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

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).
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
800 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 years

  2. 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.

    Time frame: 3 years

07

Study locations

8 sites
  • Instituto Alexander Fleming
    Buenos Aires, C1426NZ, Argentina
  • Pontificia Universidad Católica de Chile
    Santiago, 8331150, Chile
  • Instituto Nacional de Cancerología
    Mexico, 01480, Mexico
  • VU Medical Centre
    Amsterdam, 1081, Netherlands
  • GenPat
    Asunción, Paraguay
  • Institute of Pathology and Immunology of University of Porto
    Porto, 4200 135, Portugal
  • Fundació Privada Institut d'Investigació Oncològica de Vall-Hebron (VHIO)
    Barcelona, 08035, Spain
  • Fundación Investigación Clínico de Valencia
    Valencia, 46010, Spain
08

References and documents

Publications

  • 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. PubMed 35692051 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2019 to primary completion in Dec 2023, 53 months.

Of 322 non-industry observational studies under Stomach Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 171. This study's 53 months is close to that.

Counting every sponsor, half of 364 studies reached it within 54 months; a quarter within 29 and three quarters within 119.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 5, 2019
First posted
Jul 15, 2019
StartActual
Jul 30, 2019
Primary completionActual
Dec 31, 2023
CompletionActual
Dec 31, 2023
Last update
May 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04019808
Lead sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
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
First posted
Jul 15, 2019
Start date
Jul 30, 2019
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023
Last update
May 9, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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