National Database on Primary Biliary Cholangitis

Recruiting now

Conditions studied: Primary Biliary Cholangitis

In brief

Primary biliary cholangitis (PBC) is a rare, autoimmune, cholestatic liver disease. No data about the disease epidemiology exist in Italy. Therefore this study aims to develop a national PBC patient database linked to a biological sample storage.

Key facts

Study ID

NCT05151809

Run by

University of Milano Bicocca

People needed

6000

Starts

2019-09-19

Expected to finish

2029-01-24

Last updated by the study team

2025-07-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All PBC patients living in Italy and aged at least 18 years can be included in the database. According to well-established criteria, PBC is diagnosed in subjects who fulfill two of the three of following criteria:
• elevated alkaline phosphatase and /or GGT;
• positive anti-mitochondrial autoantibodies (titer ≥ 1:40) or PBC-specific antinuclear antibodies (gp-210 and sp100);
• characteristic histological features of florid bile ducts lesions and granulomatous lesion.

You may not qualify if…

• The patient has explicitly declared his/her unwillingness to participate to the study

Where it is running

• AOU di Modena- U.O. Gastroenterologia — Modena, Italy (enrolling)
• UO di gastroenterologia, Asst Papa Giovanni XXIII — Bergamo, Italy (enrolling)
• Ospedali riuniti di Ancona — Ancona, Italy (enrolling)
• UO epatologia, Istituto scientifico universitario San Raffaele — Milan, Italy (enrolling)
• Gastroenterologia, fisiopatologia e endoscopia digestiva, Azienda sanitaria dell'alto adige — Bolzano, Italy (enrolling)
• Unità epatologica ed ecografia internistica a valenza dipartimentale, Fondazione Ospedaliera Poliambulanza — Brescia, Italy (enrolling)
• Policlinico S. Orsola Malpighi- UO Medicina Interna — Bologna, Italy (enrolling)
• UO epatologia, Azienda ospedaliero università di Cagliari Policlinico universitario Monserrato — Cagliari, Italy (enrolling)
• A.O.U. Consorziale - Policlinico Bari- UO Gastroenterologia — Bari, Italy (enrolling)
• UO epatologia Ospedale Garibaldi — Catania, Italy (enrolling)
• UO di fisiopatologia digestiva, Azienda Ospedaliera Universitaria Mater Domini — Catanzaro, Italy (enrolling)
• UO di gastroenterologia, Ospedale Valduce — Como, Italy (enrolling)
• Azienda Socio Sanitaria Territoriale (ASST) di Cremona- UO Medicina Interna - Ambulatori di Epatologia — Cremona, Italy (enrolling)
• Presidio Ospedaliero di Faenza- UO Medicina Interna — Faenza, Italy (enrolling)
• UO Clinica Medica, Azienda Ospedaliera Universitaria Careggi Firenze — Florence, Italy (enrolling)
• Centro C.U.R.E. Centro Universitario per la ricerca e la Cura delle Malattie Epatiche — Foggia, Italy (enrolling)
• Ambulatorio di Malattie del Fegato, U.O. Medicina, ASST Valle Olona, Presidio di Gallarate — Gallarate, Italy (enrolling)
• UO Clinica Gastroenterologica, Policlinico San Martino — Genova, Italy (enrolling)
• Centro Medicina del Viaggiatore e delle Migrazioni, ASP Catanzaro, Presìdio Ospedaliero "Giovanni Paolo II" — Lamezia Terme, Italy (enrolling)
• Ospedale IRCCS Saverio De Bellis- UOC di Gastroenterologia 1 — Castellana Grotte, Italy (enrolling)
• University of Milano-Bicocca — Milan, Italy (enrolling)
• Policlinico di Milano — Milan, Italy (enrolling)
• UO di epatologia, Ospedale Niguarda Ca' Granda — Milan, Italy (enrolling)
• UO di Epatologia, Ospedale San Giuseppe — Milan, Italy (enrolling)
• Struttura Complessa di Medicina ad Indirizzo Metabolico Nutrizionale, Dipartimento Ospedaliero di Medicina Interna — Modena, Italy (enrolling)

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