NCT05151809Recruiting
National Database on Primary Biliary Cholangitis
Multicenter, Nationwide, Observational, Retrospective and Prospective Study Based on the Development of a Patients Database Linked to a Biological Sample Storage
Source: ClinicalTrials.gov · Last updated 25 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 6000 (estimated)
- First submitted
- 15 Nov 2021
- Start date
- 19 Sept 2019
- Primary completion date
- 24 Jan 2029
- Lead sponsor
- University of Milano Bicocca
- Diseases
- Primary biliary cholangitis
- NCT number
- NCT05151809
What you commit to
- Study type: Observational
- Planned participants: 6000
- From 19 Sept 2019 to the primary completion date, 24 Jan 2029
- 55 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- The patient has explicitly declared his/her unwillingness to participate to the study
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (55)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ospedali Riuniti di Ancona Coordinator of this site? Confirm its status | Ancona | Italy | Recruiting |
| A.O.U. Consorziale - Policlinico Bari- UO Gastroenterologia Coordinator of this site? Confirm its status | Bari | Italy | Recruiting |
| UO di gastroenterologia, Asst Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Recruiting |
| Policlinico S.Orsola Malpighi- Ambulatorio di epatologia e gestione trapianto epatico Coordinator of this site? Confirm its status | Bologna | Italy | Not yet recruiting |
| Policlinico S. Orsola Malpighi- UO Medicina Interna Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Gastroenterologia, fisiopatologia e endoscopia digestiva, Azienda sanitaria dell'alto adige Coordinator of this site? Confirm its status | Bolzano | Italy | Recruiting |
| Unità epatologica ed ecografia internistica a valenza dipartimentale, Fondazione Ospedaliera Poliambulanza Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| UO di gastroenterologia, Spedali civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Not yet recruiting |
| UO epatologia, Azienda ospedaliero università di Cagliari Policlinico universitario Monserrato Coordinator of this site? Confirm its status | Cagliari | Italy | Recruiting |
| Ospedale IRCCS Saverio De Bellis- UOC di Gastroenterologia 1 Coordinator of this site? Confirm its status | Castellana Grotte | Italy | Recruiting |
| UO epatologia Ospedale Garibaldi Coordinator of this site? Confirm its status | Catania | Italy | Recruiting |
| UO di fisiopatologia digestiva, Azienda Ospedaliera Universitaria Mater Domini Coordinator of this site? Confirm its status | Catanzaro | Italy | Recruiting |
| UO di gastroenterologia, Ospedale Valduce Coordinator of this site? Confirm its status | Como | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale (ASST) di Cremona- UO Medicina Interna - Ambulatori di Epatologia Coordinator of this site? Confirm its status | Cremona | Italy | Recruiting |
| Presidio Ospedaliero di Faenza- UO Medicina Interna Coordinator of this site? Confirm its status | Faenza | Italy | Recruiting |
| UO Clinica Medica, Azienda Ospedaliera Universitaria Careggi Firenze Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Centro C.U.R.E. Centro Universitario per la ricerca e la Cura delle Malattie Epatiche Coordinator of this site? Confirm its status | Foggia | Italy | Recruiting |
| Ambulatorio di Malattie del Fegato, U.O. Medicina, ASST Valle Olona, Presidio di Gallarate Coordinator of this site? Confirm its status | Gallarate | Italy | Recruiting |
| UO Clinica Gastroenterologica, Policlinico San Martino Coordinator of this site? Confirm its status | Genova | Italy | Recruiting |
| Centro Medicina del Viaggiatore e delle Migrazioni, ASP Catanzaro, Presìdio Ospedaliero "Giovanni Paolo II" Coordinator of this site? Confirm its status | Lamezia Terme | Italy | Recruiting |
| UO di epatologia clinica e biomolecolare, Università degli studi di Messina Coordinator of this site? Confirm its status | Messina | Italy | Not yet recruiting |
| UO di Epatologia, Ospedale San Giuseppe Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| University of Milano-Bicocca Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| UO epatologia, Istituto scientifico universitario San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Policlinico di Milano Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| UO di epatologia, Ospedale Niguarda Ca' Granda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Struttura Complessa di Medicina ad Indirizzo Metabolico Nutrizionale, Dipartimento Ospedaliero di Medicina Interna Coordinator of this site? Confirm its status | Modena | Italy | Recruiting |
| AOU di Modena- U.O. Gastroenterologia Coordinator of this site? Confirm its status | Modena | Italy | Recruiting |
| Università della Campania Luigi Vanvitelli di Napoli- Dipartimento di epato-gastroenterologia Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Day Hospital e Ambulatorio di Epatoogia e Nutrizione Clinica, Fondazione Evangelica Villa Betania, Ospedale generale di Zona Coordinator of this site? Confirm its status | Naples | Italy | Not yet recruiting |
| Ospedale policlinico Federico II di Napoli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| UO medicina ed epatologia, Ospedale maggiore della carità Coordinator of this site? Confirm its status | Novara | Italy | Recruiting |
| UO di Medicina Interna, Azienda Ospedaliera di Padova Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| UO di Gastroenterologia, Azienda ospedaliera di Padova Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| UO gastroenterologia, Policlinico Paolo Giaccone Coordinator of this site? Confirm its status | Palermo | Italy | Recruiting |
| Malattie infettive ed epatologia, Azienda ospedaliero universitaria di Parma Coordinator of this site? Confirm its status | Parma | Italy | Recruiting |
| Day Hospital Internistico e ambulatorio di Epatologia, ASL Pescara Coordinator of this site? Confirm its status | Pescara | Italy | Recruiting |
| UO epatologia, AOU pisana Cisanello Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| S.C. Gastroenterologia, Ospedale di Pordenone, AS FO Coordinator of this site? Confirm its status | Pordenone | Italy | Recruiting |
| Policlinico Universitario Fondazione Agostino Gemelli- UO di medicina interna Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Medicina clinica ed epatologia, Policlinico universitario campus bio-medico Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| UO di Epatologia, Universita' di Roma Tor Vergata Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| UO di Gastroenterologia, Policlinico Umberto I Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Medicina interna ed epatologia, Istituto clinico Humanitas Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| Università degli studi di Salerno Coordinator of this site? Confirm its status | Salerno | Italy | Recruiting |
| UO di Gastroenterologia e Endoscopia Digestiva, Ospedale Casa Sollievo della Sofferenza Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Recruiting |
| SSD Epatologia, Fondazione Casa Sollievo della Sofferenza Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Not yet recruiting |
| Azienda Ospedale Universitaria di Sassari- UOC Medicina Interna Coordinator of this site? Confirm its status | Sassari | Italy | Recruiting |
| S.C. Gastroenterologia, Azienda Ospedaliero-Universitaria Molinette Coordinator of this site? Confirm its status | Torino | Italy | Recruiting |
| Gastroenterologia ed endoscopia digestiva, Azienda provinciale per i servizi sanitari Coordinator of this site? Confirm its status | Trento | Italy | Recruiting |
| Ospedale regionale Ca' Foncello di Treviso- Unità operativa complessa di Gastroenterologia Coordinator of this site? Confirm its status | Treviso | Italy | Recruiting |
| SC (UCO) Clinica Patologie del Fegato, Ospedale di Cattinara, ASU GI Coordinator of this site? Confirm its status | Trieste | Italy | Recruiting |
| SOS di DPT Epatologia e Trapianti di Fegato, ASU FC Coordinator of this site? Confirm its status | Udine | Italy | Recruiting |
| UO di gastroenterologia ed endoscopia digestiva, Azienda macchi, Asst sette laghi Coordinator of this site? Confirm its status | Varese | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Integrata Verona- UOC Gastroeneterologia A Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.