Clinical trial Recruiting at 1 site Observational Ages 17 and up

National database for patients with primary sclerosing cholangitis

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

Run by University of Milano Bicocca · NCT05618145 · Data updated 2026-11-12

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
Ages17 Years and up
SexAll
Enrollment6000 (estimated)
SponsorUniversity of Milano Bicocca
Academic / other
Locations63 sites (Ancona and 62 other locations)
StatusRecruiting
StartedOctober 21, 2022
Main results expectedOctober 21, 2032
Study endsOctober 21, 2032
Registry record updatedJanuary 2, 2024
Trial IDNCT05618145 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

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

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • ASST Monza
    Monza, Italy
    Recruiting
  • Ospedali riuniti di Ancona
    Ancona, Italy
    Not yet recruiting
  • Policlinico di Bari
    Bari, Italy
    Not yet recruiting
  • ASST Bergamo ovest
    Bergamo, Italy
    Not yet recruiting
  • ASST Papa Giovanni XXIII
    Bergamo, Italy
    Not yet recruiting
  • Ospedale Sant'Orsola Malpighi
    Bologna, Italy
    Not yet recruiting
Show 44 more locations
  • Policlinico S. Orsola Malpighi
    Bologna, Italy
    Not yet recruiting
  • Azienda sanitaria dell'Alto Adige
    Bolzano, Italy
    Not yet recruiting
  • Spedali civili
    Brescia, Italy
    Not yet recruiting
  • Unità epatologica ed ecografia internistica a valenza dipartimentale, Fondazione Ospedaliera Poliambulanza
    Brescia, Italy
    Not yet recruiting
  • Policlinico universitario Monserrato
    Cagliari, Italy
    Not yet recruiting
  • Presidio Ospedaliero San Michele ARNAS G. Brotzu
    Cagliari, Italy
    Not yet recruiting
  • Osp. "S de Bellis" - IRCCS
    Castellana Grotte, Italy
    Not yet recruiting
  • UO epatologia Ospedale Garibaldi
    Catania, Italy
    Not yet recruiting
  • Azienda Ospedaliera Universitaria Mater Domini
    Catanzaro, Italy
    Not yet recruiting
  • Azienda Ospedaliera Universitaria- Mater Domini
    Catanzaro, Italy
    Not yet recruiting
  • Ospedale Valduce
    Como, Italy
    Not yet recruiting
  • Unità operativa complessa di medicina interna- Azienda ospedaliera di Cosenza
    Cosenza, Italy
    Not yet recruiting
  • ASST di Cremona
    Cremona, Italy
    Not yet recruiting
  • Ospedale santa croce
    Cuneo, Italy
    Not yet recruiting
  • Presidio Ospedaliero di Faenza (RA)
    Faenza, Italy
    Not yet recruiting
  • Azienda Ospedaliero-Universitaria di Ferrara
    Ferrara, Italy
    Not yet recruiting
  • Azienda ospedaliera universitaria careggi Firenze
    Florence, Italy
    Not yet recruiting
  • Azienda ospedaliera universitaria Careggi
    Florence, Italy
    Not yet recruiting
  • Centro C.U.R.E. Centro Universitario per la ricerca e la Cura delle Malattie Epatiche
    Foggia, Italy
    Not yet recruiting
  • Ospedale Casa Sollievo della Sofferenza
    Foggia, Italy
    Not yet recruiting
  • ASST Valle Olona
    Gallarate, Italy
    Not yet recruiting
  • Policlinico San Martino
    Genova, Italy
    Not yet recruiting
  • Presìdio Ospedaliero "Giovanni Paolo II"
    Lamezia Terme, Italy
    Not yet recruiting
  • ASST Lecco
    Lecco, Italy
    Not yet recruiting
  • UO di epatologia clinica e biomolecolare. Università degli studi di Messina
    Messina, Italy
    Not yet recruiting
  • Az. Ospedaliera San Paolo- Polo universitario
    Milan, Italy
    Not yet recruiting
  • Istituto scientifico universitario San Raffaele
    Milan, Italy
    Not yet recruiting
  • Ospedale Niguarda Ca' Granda
    Milan, Italy
    Not yet recruiting
  • Ospedale San Giuseppe
    Milan, Italy
    Not yet recruiting
  • Policlinico di Milano
    Milan, Italy
    Not yet recruiting
  • Dipartimento Ospedaliero di Medicina Interna
    Modena, Italy
    Not yet recruiting
  • Fondazione Evangelica Villa Betania, Ospedale generale di Zona
    Naples, Italy
    Not yet recruiting
  • Ospedale policlinico Federico II di Napoli
    Naples, Italy
    Not yet recruiting
  • Università della Campania Luigi Vanvitelli
    Naples, Italy
    Not yet recruiting
  • Ospedale maggiore della carità
    Novara, Italy
    Not yet recruiting
  • Azienda Ospedaliera di Padova
    Padova, Italy
    Not yet recruiting
  • UO di Gastroenterologia Azienda ospedaliera di Padova
    Padova, Italy
    Not yet recruiting
  • Policlinico Paolo Giaccone
    Palermo, Italy
    Not yet recruiting
  • Azienda ospedaliero universitaria di Parma
    Parma, Italy
    Not yet recruiting
  • Istituto Clinico Città di Pavia-Gruppo Sandonato
    Pavia, Italy
    Not yet recruiting
  • Azienda ospedaliera di Perugia
    Perugia, Italy
    Not yet recruiting
  • Day Hospital Internistico e ambulatorio di Epatologia, ASL Pescara
    Pescara, Italy
    Not yet recruiting
  • Aou pisana Cisanello
    Pisa, Italy
    Not yet recruiting
  • Ospedale di Pordenone AS FO
    Pordenone, Italy
    Not yet recruiting

+13 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 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.