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CompletedNCT03957031LEGACY-1Updated May 9, 2024

Gastric Cancer Risk Factors Associated With EU and CELAC Populations

An observational study in Cancer, Gastric, 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, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-09.

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

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
1,600
Ages
18 Years to 90 Years
Sex
All
01

Study 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

Read the 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
02

Conditions studied

  • Cancer, Gastric

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 1,600 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
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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
1,600 participants (actual)
Patient registry
No

Groups and cohorts

  • Cases

    Patients with a pathological confirmation of GC diagnosis

  • Control

    Patients with confirmed absent of GC

06

What researchers measure

Primary outcomes

  1. Exposure to a variety of potential sources of GC risk factors

    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.

    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 City, 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
  • Hospital Clínico Universitario 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 May 2019 to primary completion in Dec 2023, 55 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 55 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
May 17, 2019
First posted
May 21, 2019
StartActual
May 31, 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
NCT03957031
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
May 21, 2019
Start date
May 31, 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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