Periodic Reporting for period 5 - ImmUniverse (Better control and treatment of immune-mediated diseases by exploring the universe of microenvironment imposed tissue signatures and their correlates in liquid biopsies)
Reporting period: 2024-01-01 to 2024-12-31
Regarding retrospective studies, UC and AD biomaterial analysis has initiated, generating Omics data at different levels from blood/serum, biopsies and FFPE tissue samples across the entire Consortium.
The mapping and transformation of four retrospective cohorts and the UC and AD prospective data into the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) is completed.
Currently, 68% of patient recruitment has been achieved for AD, with 202 out of 300 patients enrolled, Meanwhile, the recruitment target for ulcerative colitis (UC) has been fully met, with 270 patients enrolled.Two new clinical sites that have joined the Consortium contribute to increase AD recruitment efforst .
dOFM as non-invasive liquid biopsy technology for AD is actively recruiting (12 patients included) and an interim report has been circulted with preliminary data generated. Moreover, retrospective data from a previous dOFM study has been made available to ImmUniverse and is currently being integrated to provide robust data. LIPUS as non-invasive liquid biopsy technology for UC has been validated in murine models of colitis and translational activities are ongoing for application in human UC patients. A favourable ethics vote and approval from the Italian Ministry of Health has been obtained for the LIPUS Clinical Study, thus leading to study commencement in the following period also in an newly-joined center that will aid recruitment. ImmUniverse created general awareness by producing communication materials such as a flyer, social media designs, an interview clip on dOFM, lay summaries of publications, an animated clip and an FAQ article. Social Media campaigns are ongoing and the audience is increasing. First manuscripts have been published and partners represented the project at conferences.