NCT04015466

Advanced GC Multi-omic Characterization in EU and CELAC Populations

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 800 (actual)
• Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: —

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-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.

Conditions

• Gastric Cancer

Timeline

• Start date: 2019-06-12
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2019-07-11
• Last updated: 2024-05-09

Locations

8 sites across 7 countries: Argentina, Chile, Mexico, Netherlands, Paraguay, Portugal, Spain