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Sectors: Health

Regions: European Union, Worldwide

Category: Call for proposals


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Eligible countries
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Responsible: European Commission


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The global objectives of this call for proposals are:
– Develop diagnostic biomarkers that are relatively non-invasive (i.e. blood-based or imaging) for NASH and those that are useful across the spectrum of NAFLD.
– Identify biomarkers that can predict disease progression for NASH.
– Qualification of preclinical models of NASH.

Priorities and funded actions:

– Identify and qualify diagnostic biomarkers for NASH and across the spectrum of NAFLD. 
– to provide validation of the previously-identified diagnostic NASH and NAFLD biomarkers using an independent cohort.
– Collect and extend longitudinal clinical data to identify biomarkers that predict disease progression. 

– Make substantial progress in identifying biomarkers that track progression of the NAFLD spectrum including NASH.  

Among financed actions
– Overall project co-ordination and integration and dissemination (Phases 1a and 1b)
– Management and integration of existing databases with a key focus on identification of candidate NAFLD and NASH biomarker(s) using the Phase 1a cohort data.
– Central laboratory assay development and implementation using samples from the clinical cohorts (Phases 1a and 1b).
– Clinical replication and validation of the biomarker(s) that have been identified using Phase 1a data in a separate Phase 1b cohort. Collection of patient reported outcomes in the Phase 1b cohort, and if feasible from data obtained in the Phase 1a cohort, is another important goal of this work package
– Qualification of clinical imaging modalities of NAFLD and NASH (and stages of NASH) within the context of relationships to liver biopsy data and soluble biomarker data, together with other ancillary data including genetic information.
– Development and qualification of relevant preclinical disease models (rodent and non-rodent) for NAFLD and NASH that can demonstrate fidelity to clinical pathobiology.