Project SHIELD aims to transform the early detection and monitoring of pancreatic cancer. The projects combines cutting-edge multiplex immunoassays with artificial intelligence to identify high-risk individuals with greater accuracy and speed.
SHIELD's innovative approach
The SHIELD project aims to address the current challenges in early pancreatic cancer detection by validating an innovative blood-based diagnostic test, specifically developed for early identification of pancreatic ductal adenocarcinoma (PDAC) in high-risk individuals. As part of its efforts, SHIELD will also pilot an early detection program in Greece, Slovenia, and Lithuania.
Developed by project partner Reccan, this novel test uses a 5-plex multiple immunoassay to analyze protein readouts and generate a probability score for pancreatic cancer. Early studies involving over 450 samples have shown outstanding performance, with sensitivity exceeding 91% and specificity greater than 96%.
SHIELD’s plan includes the clinical validation of the test in a prospective, multi-center study across seven EU countries, focusing on individuals with familial or genetic risk factors.
Additionally, the project seeks to identify new protein biomarkers for other risk indicators such as new-onset diabetes (NOD). Collaboration with national screening authorities will support the integration of the test into existing healthcare programs, while partnerships with patient organizations aim to boost recruitment and ensure access for those who need it most.
Looking ahead to 2035, SHIELD envisions a fundamental transformation in pancreatic cancer diagnostics, with the ambitious goal of raising the 5-year survival rate in Europe to 30%. This crucial initiative forms part of the European Cancer Mission’s efforts in the area of prevention and early detection of heritable cancers.
SHIELD methodology
The SHIELD project is built upon a carefully structured methodological approach, organized into distinct phases designed to revolutionize early detection of pancreatic cancer.
Phase 1: Building the AI-powered foundation
The initial phase is all about developing the robust, AI-empowered platform. This cutting-edge platform will be central to every identification strategy within our surveillance program and will manage the clinical study data
Phase 2: Identifying high-risk individuals
We’ll focus on developing and implementing precise identification strategies. This includes a thorough assessment of an individual’s heritable genetic risk for pancreatic ductal adenocarcinoma (PDAC), determining their eligibility for inclusion in the SHIELD surveillance program for early detection.
Phase 3: Launching the surveillance program and clinical validation
Once high-risk individuals are successfully identified and recruited, the project moves into Phase 3: implementing the surveillance program and launching the crucial clinical validation study.
Phase 4: Validating and expanding biomarkers
Clinical samples will undergo rigorous analysis using the GMP-manufactured Reccan-IA. This process adheres to strict regulatory guidelines to ensure the validation of our study endpoints. Additionally, we’ll implement a biomarker discovery pipeline to expand the test’s applications to other high-risk groups.
Final phase: Integration and impact
In the project’s final phase, we’ll adopt a multifaceted approach. This includes robust communication efforts, health technology assessment, proactive policymaking, and strategic exploitation of our innovation. The ultimate goal is to seamlessly integrate SHIELD into existing screening programs, maximizing its impact on pancreatic cancer early detection.
SHIELD outcomes
The SHIELD project has a bold ambition: to pilot a comprehensive surveillance program tailored specifically for individuals with a high inherited genetic risk for pancreatic cancer.
Our goal is to co-create this program hand-in-hand with key partners, including patient organizations, leading experts, and national screening authorities in our target regions. This collaborative approach will help us develop a scalable model that can seamlessly integrate into existing national screening initiatives, much like the successful programs already in place for colorectal, breast, and cervical cancers.
Reaching more people, expanding access
We’re committed to expanding our reach and raising awareness through an innovative online recruitment platform. This platform isn’t just a website; it’s a dynamic tool designed to engage a broader audience, including those in remote areas, through interactive features like AI-driven chats and comprehensive educational resources. By offering free risk assessments for individuals with a family history of pancreatic cancer, the SHIELD platform will provide accessible and proactive opportunities for those at higher risk.
Making genetic testing routine
There is an urgent unmet clinical need to enhance early detection of pancreatic cancer to improve patient outcomes, significantly meliorate their quality of life, and reduce mortality rates. The current practice in many countries in Europe and the US has significant gaps in effectively identifying high-risk individuals and employing targeted surveillance strategies. To address these gaps, a multi-faceted approach is required. First, the identification of individuals with a heritable genetic risk is crucial. Expanding access to genetic testing for those with a family history of pancreatic cancer, especially among first-degree relatives, is essential to recognise individuals at significantly higher risk due to genetic predispositions such as BRCA2, CDKN2A, PRSS1, and STK11/LKB1 mutations.
These individuals should be the primary focus of enhanced surveillance programs. Second, there is a need for designing effective surveillance programs that utilise improved biomarker tests. These programs should be tailored to monitor high-risk populations closely, initiating screening at younger ages based on specific genetic profiles. Finally, the development of novel, easy-to-use, accessible, and cost-effective early detection methods, such as routine blood-based tests, is imperative. Currently, no FDA-approved or CE-IVD biomarker tests exist for the early detection of PDAC. These new methods must exhibit high sensitivity for early stage PDAC and specificity, within high-risk groups. Addressing these clinical needs will be critical to reducing the burden of pancreatic cancer and improving survival outcomes across EU and the world.