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Comprehensive Surveillance of High-risk Individuals and Health Integration for Early detection of Pancreatic cancer utilising innovative multiplex immunoassays

Project description

A new blood test with high accuracy for pancreatic cancer

Early detection of pancreatic ductal adenocarcinoma (PDAC) can boost survival to 42 % with surgery, highlighting the need for improved screening, especially for those with genetic predispositions. The FDA-approved biomarker CA19-9 is primarily for monitoring treatment and lacks sufficient sensitivity for early detection. The EU-funded SHIELD project will enhance early PDAC detection through a new blood-based diagnostic test specifically for high-risk individuals. This test uses a 5-plex multiple immunoassay to provide a probability score for cancer. It has shown over 91 % sensitivity and 96 % specificity in preliminary studies. The project will conduct a multi-centre validation across seven EU countries and explore new protein biomarkers for conditions like new-onset diabetes.

Objective

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)

Fields of science (EuroSciVoc)

Keywords

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Topic(s)

Funding Scheme

HORIZON-IA - HORIZON Innovation Actions

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Call for proposal

(opens in new window) HORIZON-MISS-2024-CANCER-01

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Coordinator

Univerzitetni klinicni center Maribor
Net EU contribution
€ 665 000,00
Address
LJUBLJANSKA ULICA 5
2000 Maribor
Slovenia
Region
Slovenija Vzhodna Slovenija Podravska
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
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Total cost
€ 665 000,00

Participants (25)

Partners (1)