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

Periodic Reporting for period 1 - DIOPTRA (EARLY DYNAMIC SCREENING FOR COLORECTAL CANCER VIA NOVEL PROTEIN BIOMARKERS REFLECTING BIOLOGICAL INITIATION MECHANISMS)

Berichtszeitraum: 2023-01-01 bis 2024-06-30

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 definite 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 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.
On a general note, 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.
The first stage of the project has 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. Specifically, DIOPTRA has successfully acquired biological samples to proceed with the identification of new CRC biomarkers among a large pool of approximately 3000 candidate proteins, and the required equipment having been set-up and prepared for analysis. In addition, all the processes for the finalisation and kick-off of the prospective clinical study of DIOPTRA have been completed, with data collection having initiated across the participating EU clinical sites in order to recruit the required population for validation of the projects’ biomarkers and screening tool. Data collection and analysis will be based on a CRC-specific data ontology that was created within the project via close collaboration of clinical and technical experts. From a technical perspective, the project has successfully set-up a web-based platform available to all clinical sites for data collection, storage, and monitoring, enabling both, clinical experts to organise and seamlessly store their data, and technical experts to have direct access for data analysis. The project has also applied measures to ensure enhanced data anonymity, in order to safeguard the participants’ information.
Since the work so far has been mostly preparatory for the main analysis and clinical studies, no results beyond the state of the art are to be reported at this stage. Completed actions have focused on maximising the high-quality of the data analysis and the clinical study implementation processes, so the project is ready to proceed in its next phase that is expected to generate novel results beyond the state of the art. Specifically, the risk factor analysis and the biomarker discovery are expected to yield results on new CRC features of high significance for prevention and screening, with especially the biomarker discovery being planned to identify the candidate biomarkers for minimally-invasive CRC screening based on blood sampling. Concurrently, the first version of the DIOPTRA mobile app is under development, designed to offer a holistic package on CRC awareness and prevention not currently available to the public via similar tools.
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