EARLY DYNAMIC SCREENING FOR COLORECTAL CANCER VIA NOVEL PROTEIN BIOMARKERS REFLECTING BIOLOGICAL INITIATION MECHANISMS

Project Information

DIOPTRA

Grant agreement ID: 101096649

DOI

10.3030/101096649

EC signature date 28 November 2022

Start date 1 January 2023

End date 31 December 2026

Funded under

• Health

Total cost

€ 13 647 600,80

EU contribution

€ 13 646 550,50

Coordinated by

EREVNITIKO PANEPISTIMIAKO INSTITOUTO SYSTIMATON EPIKOINONION KAI YPOLOGISTON
Greece

Periodic Reporting for period 2 - DIOPTRA (EARLY DYNAMIC SCREENING FOR COLORECTAL CANCER VIA NOVEL PROTEIN BIOMARKERS REFLECTING BIOLOGICAL INITIATION MECHANISMS)

Reporting period: 2024-07-01 to 2025-12-31

Summary of the context and overall objectives of the project

Colorectal cancer (CRC) is the third most common tumour in men and the second in women, and its incidence is projected to rise significantly by 2040. Survival rates and the prevention of metastasis are highly dependent on reliable early detection. However, the current participation of the general population in screening programmes is very poor, mainly due to the most reliable and established procedure (colonoscopy) not appealing to a large number of citizens, who neglect screening. What is more, CRC is steadily appearing at younger ages, so even more individuals should be eligible for screening. Given the fact that the transition from a healthy state to CRC might spread over 15 to 20 years, it is imperative that lesions are identified as soon as possible. Ideally, this should be achieved via a less invasive technique than colonoscopy, albeit with high reliability. In this scope, DIOPTRA aims to introduce a front-line screening tool based on a blood test utilising new protein biomarkers, combined with risk factors including medical and behavioural parameters. To that end, tissue & blood samples will be concurrently examined for the detection of prognostic proteins that are present in pre-malignant and malignant samples. If successful, the screening tool of DIOPTRA will be able to reliably identify in a minimally-invasive manner the individuals that are in definitive need for colonoscopy, while filtering out healthy citizens who will thus avoid an unnecessary colonoscopy. Advanced bioinformatics analysis and artificial intelligence (AI) will be leveraged for biomarker detection, assessment of prognostic power, and combination with risk factors. Overall, given the low citizen participation on CRC screening across EU, it is expected that such a tool will greatly broaden the evaluated population, boosting participation rates and bypassing age-related screening thresholds. Moreover, DIOPTRA is attempting to capitalise on the fact that CRC is now considered a highly preventable disease, by promoting personalised behavioural change based on modifiable risk factors disseminated to the public via a freely available mobile application, that will also include informative material to enhance awareness among the population.
DIOPTRA is operating under the Cancer Mission cluster of EU-funded projects on “Prevention and Early Detection (Screening)”, working together with similar research and innovation initiatives in alignment with the goals of Europe’s Beating Cancer Plan.

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

The first stage of the project focused on the finalisation of the clinical protocols, the preparation of the biomarker discovery work, the establishment of tools and workflows for analysing digital data, as well as the set-up of the software infrastructure for data storage and management. The focus then shifted on data collection on three fronts, including a) retrospective clinical records from collaborating hospitals, b) paired tissue and blood samples for biomarker discovery, and c) prospective data collection for analysis and validation. So far, the discovery process has elicited an initial set of protein biomarkers with promising screening and diagnostic value, investigating among more than 5000 candidate proteins. Furthermore, initial CRC risk factors have been identified based on the clinical datasets. Both processes are constantly enriched with new data from the prospective clinical study, supported by nine clinical sites in eight EU countries, in order to identify new proteins and risk factors and validate the results. So far, more than 2000 people have enrolled in the prospective study, including citizens who visit the participating hospitals to receive CRC screening services. Some of the participants have also received a mobile app to promote CRC awareness and behavioural prevention patterns, being closely monitored by the research team. Using a software platform specifically developed for the needs of DIOPTRA, clinicians upload the collected data to enable cross-country analysis. Moreover, modern AI techniques are being implemented to collectively analyse proteins and risk factors, aiming to develop the basis for a novel clinical decision support system for CRC screening.

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)

Analysis on the first batches of collected data (biological samples and clinical records) has already revealed a set of new proteins with diagnostic and screening value, which were not previously considered in research on colorectal cancer. Joint analysis with risk factors that have also been identified allows the combined use within an AI-based model for screening, potentially linking protein profiles with known -yet underutilised- clinical data.

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