Ignite Creation Date:
2024-05-06 @ 1:24 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04015466
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2019-06-05
Brief Title:
Advanced GC Multi-omic Characterization in EU and CELAC Populations
Sponsor:
Fundación para la Investigación del Hospital Clínico de Valencia
Organization:
Fundación para la Investigación del Hospital Clínico de Valencia
Study Overview
Official Title:
Advanced GC Multi-omic Characterization in EU and CELAC Populations
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
Recruiting
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LEGACY-2
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
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-stageadvanced 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None