PNRR: Italian Autoimmune Liver Disease Clinical Research Network (IT-AILD CRN)

The Italian Clinical Research Network of Autoimmune Liver Diseases is a national project aimed at strengthening the clinical and research infrastructure in the field of autoimmune liver diseases. The aim of this project is to collect clinical, epidemiological data and biological samples from participating patients and integrate them into the National Autoimmune Disease Databases (PBC, PSC and AIH) with the main purpose of enhancing awareness, knowledge, clinical management and treatment of these diseases.

OBJECTIVES

The goal of IT-AILD CRN is to enhance the clinical and scientific infrastructure of coordinated, nationwide research. The foundations of this project are represented by three main pillars:

  • Research: promote collaborative research among hepatology centers with the aim of better understanding the epidemiology and course of autoimmune liver diseases through disease registries.

  • Patient access to care: improve awareness of these diseases, and available treatments, among family physicians, gastroenterologists, hepatologists, patients, and families, including through collaboration with patient organizations and governmental and nongovernmental bodies (AISF, SIGE).

  • Development of an integrated health care system: strengthen the regional clinical network through optimization of the system of “referrals,” multidisciplinary discussion of complex clinical cases, and access to clinical trials, registered drugs, and new experimental therapies.

The implementation of multi-disease databases and a connected biobank will have a significant impact on clinical and translational research. This will make it possible to study natural history and disease variants, define cases, correlate genotype to phenotype, stratify risk, and identify relevant endpoints for clinical trials. The creation of this network will help improve patient access to treatment pathways and therapies for rare diseases, as well as facilitate evaluation of safety and therapeutic efficacy. It will also support regulatory analysis of the benefits and risks of drugs.
The project will foster collaborations between primary care, hospital facilities and centers specializing in rare diseases, with the goal of overcoming current disconnects in rare disease care. In particular, it will focus on establishing integrated, multidisciplinary regional centers for the management of patients with these diseases. One of the main goals of the IT-AILD CRN network is to ensure that there is at least one rare disease hub in each region. For this reason, the four selected operating units are evenly distributed from the North to the South of the country. Concurrently, the network will identify 20 regional hubs, each dedicated to autoimmune liver diseases, which will operate locally following the hub-and-spoke model. This facility will foster collaborative research among scientists aimed at a deeper understanding of the four rare diseases and the development of innovative approaches to the diagnosis, as well as the management and treatment of the diseases, while promoting awareness among patients and the medical community. Close collaboration with patient associations (AMAF, EpaC) will be a key element in supporting rare disease research, helping to consolidate a robust network of knowledge and support.

ROLE OF OPERATIONAL UNITS (UO) COORDINATORS

Executive Committee

  • Prof. Pietro Invernizzi (Monza)

  • Prof. Marco Carbone (Milan)

  • Prof. Fabio Piscaglia (Bologna)

  • Prof. Antonio Moschetta (Bari)

  • Prof. Vincenza Calvaruso (Palermo)

U01

The Center for the Study of Autoimmune Liver Diseases and ERN RARE-LIVER Center Foundation IRCCS San Gerardo dei Tintori, Monza, will be the national coordinator, thanks to the cooperation of Prof. Invernizzi and Prof. Carbone who co-founded the national CBP, CSP and AIH registries that enabled the development of a nationwide patient cohort. The center will oversee the development of clinical and research projects within the IT-AILD-CRN by integrating the network with existing disease and biobank databases.

UO2 and UO4

Bologna(IRCCS Azienda Ospedaliero-Universitaria S.Orsola-Malpighi) and Palermo(Azienda Ospedaliera Universitaria Paolo Giaccone), with the collaboration of Prof. Piscaglia and Prof. Calvaruso will coordinate the recruitment based on their many years of experience as founders of the ITAlian.Liver.CAncer (ITALICA), a national consortium that includes all hepatology units across the country and provides best practices from diagnosis to treatment in hepatocellular carcinoma (HCC) over the past decade. They will also bring their experience in two of the most relevant complications of cholangiopathies, namely liver cancer (Bologna) and portal hypertension (Palermo).

U03

Bari(University of Bari Aldo Moro), in addition to being a recruiting center, will coordinate the centralized analysis on the sample collected and stored in the biobank based on Prof. Moschetta’s laboratory expertise in the pathophysiology of autoimmune cholangiopathies.

ITAiLD – Italian network for research and treatment of autoimmune liver diseases

An Italian project that aims to consolidate the clinical and research infrastructure in the field of autoimmune liver disease on a national scale.

itaild@unimib.it