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National database for patients with primary sclerosing cholangitis

Multicenter, Nationwide, Observational, Prospective Study Based on the Development of a Primary Sclerosing Cholangitis Patient's Database Linked to a Biological Sample Storage

University of Milano Bicocca · NCT05618145

This study is creating a national database for people in Italy with primary sclerosing cholangitis to gather important health information and improve understanding of the disease.

Quick facts

Study typeObservational
Enrollment6000 (estimated)
Ages17 Years and up
SexAll
SponsorUniversity of Milano Bicocca (other)
Locations63 sites (Ancona and 62 other locations)
Trial IDNCT05618145 on ClinicalTrials.gov

What this trial studies

This observational study aims to create a national database for patients diagnosed with primary sclerosing cholangitis (PSC) in Italy, a rare and chronic liver disease. The study will collect clinical information and link it to a biological sample storage to better understand the disease's epidemiology and impact. PSC is associated with significant health risks, including liver failure and cancer, and the database will help in assessing the true burden of the disease in the Italian population. By gathering comprehensive data, the study seeks to improve patient outcomes and inform future research.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with primary sclerosing cholangitis who are willing to provide informed consent.

Not a fit: Patients who do not have a diagnosis of primary sclerosing cholangitis or are unwilling to participate in the study will not benefit.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the epidemiology of PSC, leading to improved management and treatment strategies for patients.

How similar studies have performed: While there is limited data on PSC in Italy, similar studies in other countries have successfully established databases that have improved understanding and treatment of the disease.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Willing and able to give informed consent prior to any study specific procedure being performed;
* Diagnosis of PSC according to the most recent published guidelines (EASL);

Exclusion Criteria:

* Subject unwilling to participate at the study

Where this trial is running

Ancona and 62 other locations

+13 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Primary Sclerosing Cholangitis, Disease phenotypes, National Database

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.