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CompletedNCT04015466LEGACY-2Updated May 9, 2024

Advanced GC Multi-omic Characterization in EU and CELAC Populations

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
Cohort
Time perspective
Prospective
Enrollment
800
Ages
18 Years to 90 Years
Sex
All
01

Study summary

Observational study (cohort type) of advanced GC patients that will be recruited prospectively to study biological factors associated with the disease and relevant clinical outcomes.

Read the detailed description

Despite of multiple attempts to improve treatment in recent decades, none strategies has improved prognosis in locally advanced stage III and IV GC. A therapeutic approach to GC based on current histological and image criteria (Tumour Node Metastasis -TNM- stage) is insufficient. Although multiple targeted agents are currently under investigation, so far, only trastuzumab and ramucirumab have demonstrated efficacy in advanced GC and have a regulatory approval. For this reason, the identification of specific targets that could be susceptible for drug inhibition, is an urgent requirement. Moreover, most studies and current international databases on late-stage/advanced GC are largely based on Asian populations, in sharp contrast tumour biology and genome of EU or CELAC populations remain poorly known.

The primary objective of this study are to:

  1. Characterize a multi-centric cohort including EU and CELAC populations diagnosed with advanced GC through a multi-omic approach including proteomics, genomics, transcriptomics, microbiome and exposome analysis due to study the determinants of GC.
  2. Identify the regional differences in EU and CELAC populations recruiting patients for this study for each omic characterization due to identify the high-risk group populations.
  3. Identify and select from the multi-omic approach those biomarkers useful for the development of an algorithm to guide the therapeutic approach for advanced GC.
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

  • Subjects >18 years old, with high diagnostic suspicion of advanced GC diagnosis (Stage III and IV)
  • 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 stages III and IV (including gastroesophageal junction cancer) and/or a gastroscopy indication due to the high diagnostic suspicion of GC as part of the study of his disease.
    • Has given and signed the IC to participate in this study.

  • Exclusion criteria:

    • Patients diagnosed with GC early disease (stage I and II) suitable for resectable strategy.

  • Withdrawal criteria:

    • Patients initially recruited with high suspicion of GC diagnosis but not confirmed by the pathological report.

Controls:

  • Inclusion criteria (only for microbiome analysis):

    • Subjects ≥18 years old.
    • Subjects to whom a gastroscopy is indicated within clinical care and is 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.
    • 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.
    • Patients with previous histopathologic diagnosis of peptic (gastric or duodenal) ulcer disease and/or atrophy or intestinal metaplasia.
    • Patients that have received antimicrobials during the 4 weeks period prior to the endoscopy.
    • Patients that have received proton pump inhibitors or H2-receptor antagonists, at least 2 weeks prior to the endoscopy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Cases

    Patients with high diagnostic suspicion of advanced GC diagnosis

  • Control

    Patients with confirmed absent of GC

06

What researchers measure

Primary outcomes

  1. Development of a new diagnostic algorithm for gastric cancer that includes molecular landscape, patient history, histopathological and environmental factors, personal microbiome and immune landscape

    The project will look for an integrative diagnostic algorithm that incorporates multi-parameter inputs and apply artificial intelligence to provide more personalized risk estimates and which will form the basis for future development of a clinical tool

    Time frame: 3 years

Secondary outcomes

  1. Proteomic analysis of gastric cancer tissue

    Determine the expression of certain proteins using ICH and ISH

    Time frame: 3 years

  2. Genomics (tumour next-generation sequencing)

    Determine differences in the genetic mutational profile of different populations

    Time frame: 3 years

  3. Transcriptomics (Nanostring immune gene expression panel)

    Determine differences in the genetic expression profile of different populations

    Time frame: 3 years

  4. Microbiota sequencing (including level of Epstein-Barr virus [EBV] DNA)

    Determine differences in the microbiota profile of different populations

    Time frame: 3 years

  5. Dietary habits as assessed by a new study-specific questionnaire

    Determine differences in dietary habits of different populations and its correlation with risk to develop gastric cancer

    Time frame: 3 years

  6. Biological risk factors as assessed through medical chart review

    Determine differences in biological risk factors of different populations and its correlation with risk to develop gastric cancer

    Time frame: 3 years

  7. Daily routines as assessed by a new study-specific questionnaire

    Determine differences daily routines of different populations and its correlation with risk to develop gastric cancer

    Time frame: 3 years

07

Study locations

8 sites
  • Instituto Alexander Fleming
    Buenos Aires, C1426ANZ, Argentina
  • Pontificia Universidad Católica de Chile
    Santiago, 8331150, Chile
  • Instituto Nacional de Cancerología de México
    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
  • Vall d'Hebron Institut d'Oncologia
    Barcelona, 08035, Spain
  • Hospital Clínico Univeristario 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 Jun 2019 to primary completion in Dec 2023, 54 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 54 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 11, 2019
StartActual
Jun 12, 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
NCT04015466
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 11, 2019
Start date
Jun 12, 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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