Advanced GC Multi-omic Characterization in EU and CELAC Populations

NCT04015466 | Completed

• 1 other identifier: LEGACY-2
• Study Type: observational
• Target: 800
• Locations: 7 countries
• Sites: 8

Brief 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.

Conditions

Gastric Cancer

Keywords

Gastric Cancer; Personalized medicine; Oncology; Solid tumor; Primary Intervention

Outcome Measures

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

  3 years

Secondary Outcomes (7)

• Proteomic analysis of gastric cancer tissue

  3 years

• Genomics (tumour next-generation sequencing)

  3 years

• Transcriptomics (Nanostring immune gene expression panel)

  3 years

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

  3 years

• Dietary habits as assessed by a new study-specific questionnaire

  3 years

Study Arms (2)

Cases

Patients with high diagnostic suspicion of advanced GC diagnosis

Control

Patients with confirmed absent of GC

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.
• 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

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead
• Instituto Nacional de Cancerologia de Mexico: collaborator
• Amsterdam UMC, location VUmc: collaborator
• Pontificia Universidad Catolica de Chile: collaborator
• Vall d'Hebron Institute of Oncology: collaborator
• INSTITUTO ALEXANDER FLEMING: collaborator
• Hospital Central del IPS: collaborator
• IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto: collaborator

Study Sites (8)

Instituto Alexander Fleming

Buenos Aires, C1426ANZ, Argentina

Location

Pontificia Universidad Católica de Chile

Santiago, 8331150, Chile

Location

Instituto Nacional de Cancerología de México

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

Vall d'Hebron Institut d'Oncologia

Barcelona, 08035, Spain

Location

Hospital Clínico Univeristario de Valencia

Valencia, 46010, Spain

Location

Related Publications (1)

• 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.

  PMID: 35692051 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Tumour Blood Stool Urine Nail

MeSH Terms

Conditions

Stomach Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

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

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: July 11, 2019
• Study Start: June 12, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

CL (1); ME (1); AR (1); PA (1); PT (1); ES (2); NL (1)