A European “shield” against colorectal cancer based on novel, more precise and affordable risk-based screening methods and viable policy pathways

Project Information

ONCOSCREEN

Grant agreement ID: 101097036

DOI

10.3030/101097036

EC signature date 28 November 2022

Start date 1 January 2023

End date 31 December 2026

Funded under

• Health

Total cost

€ 12 972 076,25

EU contribution

€ 12 972 076,00

Coordinated by

EXUS SOFTWARE MONOPROSOPI ETAIRIA PERIORISMENIS EVTHINIS
Greece

Periodic Reporting for period 1 - ONCOSCREEN (A European “shield” against colorectal cancer based on novel, more precise and affordable risk-based screening methods and viable policy pathways)

Reporting period: 2023-01-01 to 2024-06-30

Summary of the context and overall objectives of the project

Colorectal Cancer (CRC) is the third most commonly occurring cancer in men and the second most commonly occurring cancer in women. CRC can often be prevented through regular screening. Although colonoscopy-based screening programs help identify potential cancer cases early which is essential for decreasing the CRC incidence, the compliance rate of the people to perform the required screening is still too low and not the desired one due to the intrusive nature of the methods and general public perceptions. Fecal Occult Blood Testanother (FOBTs) is another widely used screening modality for CRC but has certain constrains to use, such as relatively low sensitivity and the need of multiple samplings to reach the full screening potential. Therefore there is a need for the development of novel, less intrusive screening methods that can effectively increase the screening rates for CRC through non-invasive, repeatable, cost-effective, easy-to-use, and patient-friendly procedures. This is of particular importance in different European societies and population subgroups, since an increase in the incidence of Early Onset CRC is currently noticed which is significantly associated with risk factors such as heredity, obesity, smoking, alcohol abuse and hyperlipidemia. Within this context, ONCOSCREEN develops a multi-tier diagnostic solution towards an improved CRC screening. Towards this goal, ONCOSCREEN considers various socio-economic determinants which increase the regional or national CRC risks, thus exploiting new solutions, particularly in younger high-risk individuals in our European communities. For the validation of the developed solutions, a clinical validation study is planned to conducted, to assess its effectiveness, sensitivity and specificity in detecting CRC at an early stage. During the first phase of the study, we will identify the different expression patterns of the four diagnostic solutions (ONCO-VOC, ONCO-CRISPR, ONCO-NMR, ONCO-CTC) in CRC patients and healthy controls with high risk for CRC, and also initially estimate their sensitivity and specificity. During the second phase the ONCOSCREEN solution’ performance will be clinically validated.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

During this first phase of the project (M1-M18), close collaboration of partners, along with appropriately adopted monitoring processes, led to significant achievements. The consortium made a comprehensive investigation of the health data management challenges and successfully drafted the initial system architecture of ONCOSCREEN (D4.1). Utilizing a co-design methodology, we successfully engaged clinicians, citizens, and policymakers ensuring their needs and insights were integrated into the design and development phases. This iterative process started on January 13, 2023, involving nine rounds of end-user requirement co-creation and included face-to-face and virtual collaborations. As a result of this process more than 20% of the initial technical and end-user requirements have undergone changes and this process is expected to continue until the later stages of the project (Until M29). Technical progress along the way was successfully demonstrated through Laboratory Integration Test (LIT) exercises in September and December 2023, with further refinements being made at the plenary meeting in February 2024. Special attention was also given to aligning the project with the EU AI Act, leading to the adoption of 11 novel technical requirements ensuring compliance with fundamental rights and safety, while boosting innovation.

The current version of system architecture outlines a hybrid data management model, ensuring robust security with a zero-trust framework and data anonymization. The architecture adheres to FHIR standards and SNOMED CT for standardized health data exchange. As the Cornerstone of the system architecture serves the Knowledge Model and Data Harmonization tool, which integrates data across distributed databases for colorectal cancer (CRC) diagnosis and treatment planning. To this day, a detailed presentation of their approach and implementation with examples of synthetic data and metadata has already been made.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

At the forefront of the innovative diagnostic solutions, ONCOSCREEN introduces 4 novel and non or minimally invasive breath biopsy (ONCO-VOC) and liquid biopsy tools (ONCO-CTC, ONCO-CRISPR, ONCO-NMR) all ready to be clinically validated. Briefly, ONCO-VOC aims to detect CRC-related volatile organic compounds (VOCs) in breath (devices have been manufactured successfully). ONCO-CTC focuses on capturing circulating tumor biomarkers using advanced microfluidics technology. Currently, the development of the ONCO-CTC tool kit (a provisional patent application is under preparation) towards the isolation of CTCs and diagnosis of CRC is near completion. An extension of ONCO-CTC is provisioned to enable culturing the CTCs and test different treatments (in vitro) towards precision medicine. ONCO-CRISPR employs CRISPR technology for precise CRC mutation and methylation detection by using liquid biopsy (patent under preparation, four prototypes ready) and finally ONCO-NMR (patent already filed) uses NMR to analyze glycoprotein profiles associated with CRC. These solutions push beyond the state of the art both in terms of accuracy (e.g. compared to a FIT test) but also aiming a non or minimally invasive (e.g. comparing to colonoscopy) examination for the early detection of CRC with reduced costs.

The ONCOSCREEN ecosystem is multifaceted comprising of its front-end which is a mobile app, built on a mature certified medical device platform that collects data and provides tailored advice, integrating with other tools such as a powerful risk stratification engine (ONCO-RISTE) and a multi-source data fusion system that integrates data for insights into CRC risk and detection. The ecosystem also offers platforms for Policymakers and Clinicians from which evidence-based recommendations aid policy-making and clinical decision-making with personalized suggestions. At the clinical level, the project also offers AI training platforms (ONCO-AICO and ONCO-AITI) for junior pathologists and colonoscopists aiming to enhance their training with real-time feedback. Finally, ONCO-BIOBA serves as the project’s data catalogue and ensures that collected medical samples are available for future research, enhancing data dissemination and utilization beyond the project’s lifetime.