Advanced GC Multi-omic Characterization in EU and CELAC Populations

Gastric Cancer Clinical Trial

— LEGACY-2  

Official title:

Advanced GC Multi-omic Characterization in EU and CELAC Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04015466
• Other study ID #: LEGACY-2
• Status: Completed
• Start date: June 12, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
Argentina	Instituto Alexander Fleming	Buenos Aires
Chile	Pontificia Universidad Católica de Chile	Santiago
Mexico	Instituto Nacional de Cancerología de México	Mexico
Netherlands	VU Medical Centre	Amsterdam
Paraguay	GenPat	Asunción
Portugal	Institute of Pathology and Immunology of University of Porto	Porto
Spain	Vall d'Hebron Institut d'Oncologia	Barcelona
Spain	Hospital Clínico Univeristario de Valencia	Valencia

Sponsors (8)

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

Countries where clinical trial is conducted

Argentina,  Chile,  Mexico,  Netherlands,  Paraguay,  Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proteomic analysis of gastric cancer tissue	Determine the expression of certain proteins using ICH and ISH	3 years
Secondary	Genomics (tumour next-generation sequencing)	Determine differences in the genetic mutational profile of different populations	3 years
Secondary	Transcriptomics (Nanostring immune gene expression panel)	Determine differences in the genetic expression profile of different populations	3 years
Secondary	Microbiota sequencing (including level of Epstein-Barr virus [EBV] DNA)	Determine differences in the microbiota profile of different populations	3 years
Secondary	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	3 years
Secondary	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	3 years
Secondary	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	3 years