The REVERT (taRgeted thErapy for adVanced colorEctal canceR paTients) project, financed
by the European Horizon 2020 Programme and led by the San Raffaele Research Center of
Rome, has recently launched the start-up of its clinical study. This important step of the project
is coordinated by the University Hospital ‘Tor Vergata’ of Rome and focuses on testing and
validating a predictive model in the oncology setting- supported by Artificial Intelligence – in order to
improve clinical practice and management of healthcare services for cancer patients.
University Hospital ‘Tor Vergata’, indeed, will coordinate the European clinical Centers involved in
the clinical trial, which aims at validating the clinical decision support system based on algorithms
for predicting treatment response in metastatic colorectal cancer patients.
According to the European Cancer Information System of the European Commission, “Colorectal
cancer is the third most diagnosed cancer in men (after prostate and lung cancers) and the second
one in women (after breast cancer). It is the second cause of cancer death in men (after lung
cancer) and the third one in women (after breast and lung cancers). Colon cancer and rectal
cancer are often grouped together because they have many features in common. It is estimated
that, in EU-27 countries in 2020, colorectal cancer accounted for 12.7% of all new cancer
diagnoses and 12.4% of all deaths due to cancer. That made it the second most frequently
occurring cancer (after breast cancer) and the second cause of cancer death (after lung cancer)”.
“The project stems from the experience carried out at the San Raffaele Research Center in Rome,
where an interinstitutional and multidisciplinary biobank database was created back in 2006 for the
application of Artificial Intelligence methodologies aimed at the development of predictive medicine
protocols,” explains Prof. Fiorella Guadagni, REVERT project Coordinator, Head of the BioBIM®
Biobank and associated database at San Raffaele Research Center and Full Professor of Clinical
Biochemistry and Clinical Molecular Biology at the San Raffaele Open University of Rome. “The
goal“, she says, “is to build an innovative Artificial Intelligence-based decision support system
using the experience and real-world data of several general hospitals operating in the EU
healthcare system for an innovative combinatorial therapy model, based on a personalized
medicine approach, which identifies the most effective therapeutic intervention for each individual
colorectal cancer patient“.
Through this innovative model, based on Artificial Intelligence, the aim of the study is to
personalize the therapeutic treatment of patients with unresectable metastatic colorectal cancer by
identifying the most effective intervention for each patient.
“The clinical study will test the predictive efficacy of Artificial Intelligence on a case-by-case basis
from a ‘personalized’ perspective“, explains Prof. Mario Roselli, Director of the Medical Oncology
Unit at the University Hospital Tor Vergata and Full Professor at the same University. “The
predictive algorithm“, he continues, “has been previously ‘trained’ through retrospective evaluation
of the clinical profiles of patients already treated at the Oncology Units participating in the project
and who, based on their response to treatment, has been defined as ‘responder’ or ‘non-
responder’. This algorithm, applied to new patients enrolled in the clinical study, will allow the
investigators to be supported in choosing the best therapeutic option. Finally,” Prof. Roselli
concludes, “although the REVERT trial is specifically aimed at metastatic colorectal disease, its
results are expected to have a positive impact on other types of cancer.”
Among the European partners, beyond the San Raffaele Research Center (REVERT project
Coordinator) and the University Hospital ‘Tor Vergata’, the REVERT project involves 7 Medical
Oncology Units from 3 different European countries that will be in charge for patient enrollment: the
University of Rome ‘Tor Vergata’ (clinical coordinating Center), the Careggi University Hospital of
Florence and the University Hospital of Palermo “P. Giaccone” (Italy); the Regional Institute of
Oncology of Iasi and the Clusterul Regional Inovativ de Imagistica Moleculara Structurala (both in
Romania); the Servicio Murciano De Salud (Spain).
Non-clinical partners participating in the project include: ProMIS – Programma Mattone
Internazionale Salute (Italy), responsible for dissemination and communication of the project
results, Malmo Universitet (Sweden), Umea Universitet (Sweden), Genxpro GMBH (Germany),
Bundesanstalt Fuermaterialforschung Und-Pruefung (Germany), Biovariance GMBH (Germany),
Fundacion Universitaria San Antonio (Spain), Luxembourg Institute of Health (Luxembourg) and
Olomedia (Italy).
Launch of the REVERT project clinical study PRESS RELEASE.