SHAPES aims to create the first European open Ecosystem enabling the large-scale deployment of a broad range of digital solutions for supporting and extending healthy and independent living for older individuals who are facing permanently or temporarily reduced functionality and capabilities. SHAPES builds an interoperable Platform integrating smart digital solutions to collect and analyse older individuals’ health, environmental and lifestyle information, identify their needs and provide personalised solutions that uphold the individuals’ data protection and trust.Standardisation, interoperability and scalability of SHAPES Platform sustain increased efficiency gains in health and care delivery across Europe, bringing improved quality of life to older individuals, their families, caregivers and care service providers. SHAPES Large-scale Piloting campaign engages +2k older individuals in 15 pilot sites in 10 EU Member States, including 6 EIP on AHA Reference Sites, and involves hundreds of key stakeholders to bring forth solutions to improve the health, wellbeing, independence and autonomy of older individuals, while enhancing the long-term sustainability of health and care systems in Europe. SHAPES’s multidisciplinary approach to large-scale piloting is reflected across 7 themes that, together, provide a clear understanding of the reality of European health and care systems and enable the validation of cost-efficient, interoperable and reliable innovations capable of effectively supporting healthy and independent living of older individuals within and outside the home. Building an ecosystem attractive to European industry and policy-makers, SHAPES develops value-based business models to open and scale-up the market for AHA-focused digital solutions and provides key recommendations for the far-reaching deployment of innovative digital health and care solutions and services supporting and extending healthy and independent living of older population in Europe.

Sudden cardiac death (SCD) is a major public health problem accounting for ~20% of all deaths in Europe with an estimated yearly incidence of ~350-700,000, often in patients with previous myocardial infarction (MI). In SCD, the heart suddenly and unexpectedly stops beating. If untreated, the patient dies within minutes, but SCD can be successfully prevented by an implantable cardioverter-defibrillator (ICD). The ICD is highly effective, but is associated with potentially severe complications and high healthcare costs. Based on historical evidence, guidelines recommend prophylactic ICD implantation in post-MI patients with left ventricular ejection fraction (LVEF)≤35% to prevent SCD. However, only a minority of these patients will ever need the device. In addition, in absolute numbers the majority of SCD cases occurs in patients with LVEF>35% who are currently not considered for prophylactic ICD. Due to the inherent risks and considerable health care expenditures, a personalised treatment approach for ICD implantation is urgently required. Using state-of-the-art methods and large clinical datasets from established international cohorts and registries across different European geographies, PROFID will develop a clinical decision support tool (risk score) to predict the individual SCD risk and identify those post-MI patients that will optimally benefit from an ICD. Two parallel randomised clinical trials will validate implementation of the risk score to determine ICD implantation, while health economic analyses will assess its economic impact on health care systems. A software tool for clinical use of the risk score will be implemented, and a pilot run in 3 European regions with participation of insurance companies and authorities. The unique composition of the consortium with key opinion leaders, patient organisations, large hospital chains, payers, policy makers and state authorities across Europe, will ensure implementation into routine clinical practice.

In 2020, there were an estimated 431 288 new cases of kidney cancer (Renal Cell Carcinoma, RCC) globally with 138 611 cases in Europe, leading to 179 368 deaths worldwide, including 54 054 deaths in Europe (source: IARC/Globocan). To define high priority topics in academic research and launch dedicated trials, European RCC academic physicians have gathered into a European initiative – the CARE group. Systemic therapy for RCC relies on two classes of agents: anti-angiogenic targeted therapy (Vascular endothelial growth factor Tyrosine Kinase Inhibitor- VEGFR TKI) and immune checkpoint inhibitor (ICI), targeting either PD-1/PD-L1 axis or CTLA-4. Combination therapy is standard of care (SOC) for clear cell RCC in all guidelines with either ICI-ICI or ICI-VEGFR TKI. However, no head-to-head comparison have been performed between the two approaches and patients are treated based on physician decision without clinical or biomarker factors to guide treatment selection. PD-L1 staining is, to date, the biomarker that has demonstrated its ability to enrich for overall survival benefit favoring ICI-ICI strategy in PDL1(+) and ICI-VEGFR TKI in PDL1(-) patients. CARE1 PCT is a prospective randomize phase III study, in first line setting for patients with metastatic clear cell RCC comparing ICI-ICI vs ICI-VEGFR TKI approaches stratified on PD-L1 by local determination. Primary endpoint is overall survival (OS). The trial will enroll 1250 patients over 3 years across eight European countries that are part of the CARE consortium. Study Sponsor is Gustave Roussy institute within the GETUG network for France, co-sponsor is developed through main academic networks (eg. SOGUG in Spain) and main institutions across Europe (eg. Cancer Core Europe – CCE). Study design has been develop to demonstrate that ICI-ICI is superior to ICI-VEGFR TKI in prolonging OS for PDL1(+) patients and that ICI-VEGFR TKI is superior to ICI-ICI in prolonging OS for PDL1(-) patients. CARE1 PCT has been designed and will be conducted with patient advocacy group representatives (ARTuR and IKCC) input. CARE1 is an academic phase III study designed to define the optimal combination using a pragmatic routinely implementable biomarker. Therefore, CARE1 will inform practice and has the potential to change treatment guidelines. Taken all together, CARE1 is a unique opportunity to build a large-scale platform to define new biomarker based therapy guidelines as well as to investigate quality of life, patient reported outcome and Health-Economic in front line setting, as well as pathological and blood biobank collection for further translational work. This action is part of the Cancer Mission cluster of projects on ‘Diagnosis and treatment’.

Project SANGUINE addresses the objectives raised by the Cancer Mission Call, which emerged from the growing societal challenge faced by European citizens. According to the European Cancer Information System (ECIS), each year, 2.7 million people in the EU are diagnosed with cancer. The SANGUINE project focuses on hematological malignancies, which account for 10% of those cases, and aims to target the four objectives of the Cancer Mission: (1) understanding, (2) prevention, including screening and early detection, (3) diagnosis, and (4) quality of life improvement of the patients and their relatives. The project introduces a novel minimally-invasive blood test that detects and classifies a set of hematological malignancies. The test is based on detecting a combination of epigenetic biomarkers in DNA from peripheral blood cells and in cell-free DNA. The SANGUINE test will provide superior sensitivity at low-cost which is ideal for screening purposes. This is enabled by direct fluorescent labeling of epigenetic marks in patient DNA and its analysis on a custom designed microarray – the HemaChip. SANGUINE team consists of a comprehensive and strong team of expert that will address medical, technological and social aspects of the developed diagnostic test. Expertise from the medical field includes clinical research, technology development and access to patients. This will enable optimization of the test for hematological malignancies following a user-centric approach and experiencing its implementation in “real-life” clinical settings. The social part of the team includes researchers and patient organization that will promote accessibility of the test to patients and individuals at-risk for screening, early detection and disease management, in combination with a study aiming to increase the screening rates. Ultimately, our project will provide validated reagents, HemaChips and data analysis software ready for large scale screening and early stage commercialization.