The SHIELD project seeks to revolutionise early detection of pancreatic cancer, focusing on individuals with high heritable genetic risk. Pancreatic ductal adenocarcinoma (PDAC) has a 5-year survival rate of less than 10%, primarily due to late-stage diagnosis. Consequently, 85% of PDAC cases are identified too late for curative treatment. However, early detection can significantly improve outcomes, increasing the survival rate to 42% with surgical intervention. There is a pressing need for better early detection methods, especially for those with familial or genetic predispositions. The only FDA-approved biomarker, CA19-9, is limited to monitoring treatment response due to its lack of sensitivity and specificity, while imaging methods ofter fail to detect early-stage cancers and cause a strain to the healthcare system due to their cost and limited availability. SHIELD aims to validate a new blood-based diagnostic test designed for early PDAC detection in high-risk individuals and pilot an early detection programme in Greece, Slovenia and Lithuania. Developed by partner Reccan, this test uses a 5-plex multiple immunoassay to analyze protein readouts and provides a probability score for pancreatic cancer. Initial studies with over 450 samples showed excellent performance with >91% sensitivity and >96% specificity. The project will validate the test's clinical performance in a prospective multi-center study across seven EU countries, targeting individuals with familial or genetic predispositions. It will also identify new protein biomarkers for other high-risk indications, such as new-onset diabetes (NOD). Collaboration with national screening authorities will help integrate this test into existing programs, and partnerships with patient organizations will enhance recruitment. SHIELD envisions transforming pancreatic cancer diagnostics by increasing the 5-year survival rate to 30% by 2035 in Europe. This action is part of the Cancer Mission cluster of projects on “Prevention & early detection (early detection heritable cancers)

Along the whole value chain in using data for economic purposes, guidelines and tools are required to make the business of the different stakeholders successful, and the end-users confident that none of their rights are endangered. CERTAIN addresses these needs and delivers solutions for data holders, dataspaces and AI systems providers, and AI systems deployers, which are the primary actors of the data and AI value chain. They must be compliant with applicable European regulations, must reach this compliance in a timely manner, and at reasonable cost. CERTAIN delivers guidelines and technical tools to help with compliance, to assess data quality, to measure biases in datasets, and to protect privacy. CERTAIN sets the foundation of AI certification: it translates the regulations to business terms, builds a directory of certification entities per business, develops a platform to streamline the certification process, and tools for AI system providers and certification entities so that they could respectively prepare and run a certification process. In case of security breach, not only privacy may get compromised, but also AI models may become useless and lead to extremely damageable decisions. To make sure that AI-based products are of high quality and reliability, CERTAIN develops security tools and methods, specifically suitable for dataspaces and AI systems. CERTAIN addresses the environmental footprint of the AI value chain. Innovative techniques are elaborated to reduce energy consumption when building and running AI systems. This is beneficial not only for the green deal but to reduce cost for AI stakeholders. As importantly, CERTAIN considers the end-users perspective, and provides templates and guidelines that may be used by AI systems deployers to reassure end-users on the use of their private data. The project tests its results on seven operational pilots in six different business areas, considering all the actors along the AI value chain.