REVERT - taRgeted thErapy for adVanced colorEctal canceR paTients

Interview with Fiorella Guadagni, Scientific Institute for Research, Hospitalization and Health Care (IRCCS) San Raffaele Pisana

Can you briefly describe the Institute?

The Scientific Institute for Research, Hospitalization and Health Care (IRCCS) San Raffaele Pisana – leader in the field of rehabilitation on the Italian national healthcare landscape – is devoted to guarantee excellent care and assistance to patients of any age in many fields of rehabilitation.

The IRCCS San Raffaele is the core of several clinical facilities of the San Raffaele network dedicated to multidisciplinary and specialist care activities, as well as advanced intervention models. Clinical laboratories, bio-imaging and out-patient yards provide important support to the clinic. As research is one of IRCCS San Raffaele Pisana’s founding principles, the institution performs an intense and qualified research activity thanks to the support of a modern Research Centre and an Interinstitutional Multidisciplinary Biobank (BioBIM), a cutting-edge facility for translational research in the medical area, whose multidisciplinary organization allows pluripotency, flexibility and the involvement of several areas of expertise.  The BioBIM wide network of collaborations strengthens the possibility of promoting cultural exchange at a national and international level, supporting projects, multicentre protocols and research agreements.

Which is IRCSS San Raffaele Pisana’s role in REVERT?

The REVERT consortium involves top performing research institutes, SME, as well as long established biobanks in all participating Member States, which will guarantee the access to a very large amount of data and the involvement of many clinical centres. Partners are highly skilled in AI models, data management, biomarkers discovery, and clinical oncology settings.

In this context, IRCCS San Raffaele Pisana will function as Project Coordinator ensuring a good group dynamic, providing opportunities for extracting the best from the intellectual capacity and expertise of the partners and acting as the intermediary between the Beneficiaries and the Funding Authority.  In addition to its Coordinator responsibilities San Raffaele will jointly function with the infrastructure design, which will be implemented as an ICT framework for integrating, extracting and harmonizing data from the different databases coordinated in the project and to be used in the decision support systems being developed to predict patient responses to combinatorial therapies for mCRC care. As data integrity and privacy management in compliance with current regulations (EU Reg. 2016/679, GDPR) and the EU Charter of Fundamental Rights is a key component of the REVERT project, the IRCCS San Raffaele Pisana will be supported in its role by a main international network specialized in cyber-security and legally compliant archiving of data, with operational units throughout Europe and, specifically, in all the countries participating in the REVERT initiative.

What is the project’s strategy for mCRC cancer patients?

Predictive medicine and artificial intelligence (AI) are at the heart of the European REVERT project that – using the experience and real-world data of different research institutes, clinical centers, and biobanks operating in the EU health system – aims to develop an innovative combinatorial therapy model capable of identifying more efficient and cost-effective therapeutic intervention for patients with unresectable metastatic colorectal cancer (mCRC).

To achieve this goal, a European network has been created among 22 research centres located in five European countries and several small-medium enterprises (SMEs), focusing on research and development in the field of AI-Health for the advancement of personalized medicine.

Thus, the REVERT Consortium aims to create – through the use of AI techniques – a computerized algorithm capable of personalizing the therapeutic intervention in patients with colon cancer metastases, which cannot be surgically removed. REVERT will also aim at understanding the mechanisms of age and sex-related biological factors in affecting tumour formation, since the risk of proximal large polyp transformation increases with age and female gender. The study will be carried out using the international standards on GCP (good clinical practice) and each participating centre will subject the study protocol to its ethics committee for evaluation. More than 10.000 homogeneous cases of metastatic colorectal cancer will be studied.

What is the potential of the REVERT project?

The REVERT projects holds great potentials, among which the creation of a large European network, in which SMEs will work in conjunction with research centres operating in Sweden, Germany, Romania, Luxembourg, Spain and Italy. To date, the operational synergy of the partners in the planning of the activities has been successful, which has led to a significant expansion of the population under study and which will also allow the implementation of the computerized algorithm not only with the clinical data of the patients, but also with new molecules capable of providing information on the course of the disease and on the response to drugs available today.

The identification of each patient’s individual profile will help to choose the correct target treatment for metastatic CRC patients. This approach will help to overcome the failure of a percentage of patients that do not respond to targeted therapy despite the tumour mutational status. New combination treatments, adjusted schedule and doses should offer new opportunities for mCRC patients.

A relevant impact of REVERT will be the immediate transfer of the results to the real EU healthcare system due to the collaboration of a large Consortium and an innovative multidisciplinary scientific and organizational approach that will allow an efficient and speedy development of new therapeutic strategies and new ICT competitive products in the EU oncology real setting.

Finally, the creation of a large database (REVERT Data Base – RDB) – thanks to the involvement at the European level of a significant number of certified biological banks and clinical and research centres – holds great potentials for future research, as it can be used for the further modelling of decision-making support systems also in other sectors of human health. The RDB and the AI services created, in fact, will be open to all partners during and after the completion of the project, and will be made available to all EU research Institutions who will make request for future studies.

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 848098”.

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