The primary aim of the LEGACy project is to improve gastric cancer (GC) outcomes by applying personalized medicine at the three levels of prevention in EU and CELAC populations participating in this project based on an “omics integrative epidemiology” conceptual model as a strategy to be extended worldwide.
The secondary aims of this project are to:
- Implement a personalized medicine strategy at the first level of prevention.
- Improve early GC detection through a personalized medicine strategy at the second level of prevention.
- Improve GC treatment approach through the stratification of patients for personalized medicine therapies.
- Analyse regional variations in respect to GC among the EU‐CELAC populations.
The LEGACy project is divided into 6 different Work Packages:
This Work Package will characterize patients’ cases-control sets using a multi-omics strategy and obtain consensus protocols for each technique used in this characterization. This includes the immunohistochemistry (IHC) and immune, molecular and microbiome analysis of the samples collected in this project, to stratify them according to the tumour biology characteristics of the EU and CELAC cohorts. For optimal organization, this Work Package is subdivided into 4 Work Package (A-D), one for each type of tumour characterisation.
Work Package 1A: Tissue biomarker profiling (Lead: IPATIMUP, GENPAT)
This Work Package will develop a standardized IHC protocol for a panel of biomarkers for cost-effective stratification of GC patients. It will also disclose the differences in biomarker profiles between the EU and CELAC countries.
Work Package 1B: Immune profiling (Lead: VUMC/INCAN)
This Work Package will analyse and define the different immune signatures in EU and CELAC cohorts. It will also develop a useful cost-effective method for GC immune profile testing at the clinic, based on the selected genes that define the immune signatures in these cohorts.
Work Package 1C: Molecular profiling (Lead: VHIO/PUC)
This Work Package will perform a molecular characterization of cohorts to identify the most frequent genomic events in the EU and CELAC cohorts. It will also develop a useful method for the molecular analysis of GC for the clinic, based on the selected genes that define the most frequent genomic events in GC, potentially targetables.
Work Package 1D: Microbiome profiling (Lead: IPATIMUP/PUC)
This Work Package will establish the taxonomic and functional tissue microbiome differences between GC and controls. It will also disclose the differences in gastric microbiome profiles between the EU and CELAC countries.
This Work Package will work on the strategy to integrate the epidemiological data from the cohorts studied, as well as a strategy for the early detection promotion, and the analysis of GC diagnosis delay. Its objectives are:
- Preparation of the questionnaires for the clinical studies link to this project due to collect the epidemiological data from subjects on baseline patient characteristics including age, sex, gender, ethnic, socioeconomic context and origin and lifestyle factors such as smoking and alcohol.
- Coordination of the clinical studies epidemiological data collection.
- Leading the organization of H. pylori registry in the different centres participating in this project, as well as the GC surveys.
- Analysing the different causes of GC diagnosis delay in the cohort studied.
This Work Package will collect data from both EU and CELAC cohorts and allow integrative analysis and sharing of the results. We will deliver not only the technology infrastructure and computing support for data governance but also the environment required for the analysis of multiple heterogeneous data sources, supporting the rest of the project in bioinformatic analysis and ad-hoc pipeline development. Data will be accessible to all partners with controlled access, develop data analysis platforms that allow clinical centres and experts to analyse the data in an integrated way.
Its objectives are:
- To leverage the power of cutting-edge data science technologies by linking clinical data to environmental information and molecular characterizations in order to obtain a cost-effective diagnosis algorithm that gets GC diagnosis closer to personalized medicine.
- To deliver a data repository, analysis and sharing infrastructure of the project that is co-developed with the researchers according to their needs.
- To integrate data from the training cohort and analyse results.
- To integrate data from the validation cohort and analyse results.
- To develop an optimized cost-effective algorithm for GC classification that can be implemented in the clinics for patient stratification.
This Work Package has two primary aims. The first is to transfer the advances in GC knowledge and management to clinicians and researchers involved in the project through an educational training programme. The second is to apply all the discoveries and knowledge acquired in order to transfer them to clinical practice at the participant centres in the project and evaluate the outcomes of this transfer. Its objectives are to:
- Facilitate training and communication for researchers collaborating on the different tasks of this project from CELAC and EU countries.
- Plan adapted strategies for each country to implement the H. pylori registry, the GC hospital-based registry, to facilitate access to early endoscopy and to implement the consensus protocols and the diagnosis algorithm proposed in the project.
Work Package 4A: Educational mentoring program (Lead: (ULEI)
This Work Package will facilitate communication and networking between the CELAC and EU partners that will work in each Work Package. The goal is to establish consensus protocols and to promote knowledge flow between the groups involved, taking advantage of the different areas of expertise of the members participating in this proposal.
Work Package 4B: Translation to clinical practice – specific actions (Lead: IAF)
This Work Package will analyse the usefulness of the interventional plan of the project in all the centres participating in this clinical study. It will coordinate the elaboration of a document with possible efficient strategies that could work derived from the results of this study. It will also coordinate and promote local meetings with the government health care representatives in order to disseminate the importance of implementing strategies in GC at the three levels of prevention.
This Work Package is devoted to developing a robust dissemination and communication plan to ensure engagement of the public and patients during the implementation and post-implementation phases of the project, including creating a visual identity, development of multiple social media platforms, and building an effective external stakeholder network. Its objectives are to:
- Create the plan for exploitation and dissemination of the results (PEDR) to promote the knowledge and advances originating from this project.
- Undertake the actions described in the PEDR to ensure knowledge transfer.
- Perform the engagement activities necessary to involve the public, patients and other stakeholders in the project.
- Design the project website to facilitate communication between researchers and public outreach.
This transversal Work Package involving the whole project will oversee the general coordination and management of the project and the consortium. Its objectives are to:
- Guide the development of the overall project and to focus the partners to be successful and produce the highest levels of information in the proposed objectives.
- Establish an adequate structure to manage the structural, financial, legal and ethical issues and to serve as contact with the European Commission.
- Guarantee the correct functioning of the LEGACy consortium, ensuring the reports and deliverables (scientific and financial) are delivered on time.
- To ensure that all ethical and legal principles are fulfilled.