Nationwide Study to Develop a Primary Sclerosing Cholangitis Patient Database and Biological Sample Storage in Italy

What this Trial Is About

Primary sclerosing cholangitis PSC is a rare, chronic liver disease marked by inflammation and scarring of bile ducts, leading to liver failure and increased risk of colorectal and liver cancers. Both children and adults can be affected, with a median survival of 17 years after diagnosis. PSC is a significant cause for liver transplantation in some countries, and it is closely linked to inflammatory bowel disease. This research aims to develop Italys first national PSC patient database linked with biological sample storage to better understand the diseases prevalence and characteristics. This observational study involves recruiting PSC patients across Italy aged 17 and older. Clinical and laboratory data will be collected at baseline and annually using electronic case report forms. Biological samples will also be stored to support research into patient profiles, disease progression, biomarkers, and therapy responses. The study will run for 10 years to assess long-term safety and effectiveness of new treatments and to identify patient subtypes at higher risk. Participants will provide clinical information and biological samples during their involvement. Researchers will monitor disease progression, therapy responses, and safety data over a decade. The main goal is to identify distinct patient subgroups with higher risks and to collect detailed clinical and laboratory data to improve understanding of PSC. This long-term follow-up aims to guide future treatment and management strategies for PSC patients in Italy.

National Database on Primary Sclerosing Cholangitis (PSC)