Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
6000 participants
OBSERVATIONAL
2019-09-19
2029-01-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
National Database on Primary Sclerosing Cholangitis (PSC)
NCT05618145
Detection Program for Patients With Primary Biliary Cholangitis Lost in the System
NCT05919433
Microbiological Assessment of Bile in Patients Undergone to Endoscopic Retrograde Cholangiography (ERCP): the "Microbile Registry"
NCT06115564
Clinical Utility of the Spyglass System in Primary Sclerosing Cholangitis (PSC)
NCT01556555
Early Diagnosis of Primary Biliary Cholangitis (PBC) in Patients With Positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP)
NCT07205874
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Based on these premises, the current project aims to build up a research, nation-wide infrastructure (around 60 Italian participating centres will be involved) to study the biology of PBC and, in particular, to explore why a significant group of, typically young patients fail primary therapy with UDCA, placing them at risk of developing progressive disease and needing liver transplantation (LT). The investigators will recruit patients and organise the collection of important clinical information and laboratory investigation, together with biological samples. Data will be collected in the form of electronic Case Report Forms (REDCap cloud) that will be completed by clinicians at baseline and thereafter on an annual basis. The clinical information will allow us to identify patients' clinical profiles. The biological samples will allow to understand key aspects of people's make up, including patient genes and the way their immune system works, and the differences in make up between people with different clinical phenotypes.
This research infrastructure would represent an invaluable resource for successful translational research in this field. Specifically, it would serve investigators conducting research; clinicians treating patients; epidemiologists gathering demographic data; and the drug and device industry seeking new markets. It also can represent a necessary infrastructure for the implementation of the European Reference Networks (ERN) for rare diseases, main pillars of the current EU policy framework on National Plans for research and development. The Italian PBC database would also be crucial for drug development, specifically to assess the feasibility of clinical trials, to facilitate the planning of appropriate clinical trials, to support the enrolment of patients and to assess the impact of new interventions.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PBC population residing in Italy
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:
1. elevated alkaline phosphatase and /or GGT;
2. positive anti-mitochondrial autoantibodies (titer ≥ 1:40) or PBC-specific antinuclear antibodies (gp-210 and sp100);
3. characteristic histological features of florid bile ducts lesions and granulomatous lesion.
Clinical information
The investigators will recruit PBC patients and collect important clinical information and laboratory investigation, together with biological samples.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Clinical information
The investigators will recruit PBC patients and collect important clinical information and laboratory investigation, together with biological samples.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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.
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Milano Bicocca
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ospedali riuniti di Ancona
Ancona, , Italy
A.O.U. Consorziale - Policlinico Bari- UO Gastroenterologia
Bari, , Italy
UO di gastroenterologia, Asst Papa Giovanni XXIII
Bergamo, , Italy
Policlinico S. Orsola Malpighi- UO Medicina Interna
Bologna, , Italy
Policlinico S.Orsola Malpighi- Ambulatorio di epatologia e gestione trapianto epatico
Bologna, , Italy
Gastroenterologia, fisiopatologia e endoscopia digestiva, Azienda sanitaria dell'alto adige
Bolzano, , Italy
Unità epatologica ed ecografia internistica a valenza dipartimentale, Fondazione Ospedaliera Poliambulanza
Brescia, , Italy
UO di gastroenterologia, Spedali civili di Brescia
Brescia, , Italy
UO epatologia, Azienda ospedaliero università di Cagliari Policlinico universitario Monserrato
Cagliari, , Italy
Ospedale IRCCS Saverio De Bellis- UOC di Gastroenterologia 1
Castellana Grotte, , Italy
UO epatologia Ospedale Garibaldi
Catania, , Italy
UO di fisiopatologia digestiva, Azienda Ospedaliera Universitaria Mater Domini
Catanzaro, , Italy
UO di gastroenterologia, Ospedale Valduce
Como, , Italy
Azienda Socio Sanitaria Territoriale (ASST) di Cremona- UO Medicina Interna - Ambulatori di Epatologia
Cremona, , Italy
Presidio Ospedaliero di Faenza- UO Medicina Interna
Faenza, , Italy
UO Clinica Medica, Azienda Ospedaliera Universitaria Careggi Firenze
Florence, , Italy
Centro C.U.R.E. Centro Universitario per la ricerca e la Cura delle Malattie Epatiche
Foggia, , Italy
Ambulatorio di Malattie del Fegato, U.O. Medicina, ASST Valle Olona, Presidio di Gallarate
Gallarate, , Italy
UO Clinica Gastroenterologica, Policlinico San Martino
Genova, , Italy
Centro Medicina del Viaggiatore e delle Migrazioni, ASP Catanzaro, Presìdio Ospedaliero "Giovanni Paolo II"
Lamezia Terme, , Italy
UO di epatologia clinica e biomolecolare, Università degli studi di Messina
Messina, , Italy
University of Milano-Bicocca
Milan, , Italy
Policlinico di Milano
Milan, , Italy
UO di epatologia, Ospedale Niguarda Ca' Granda
Milan, , Italy
UO di Epatologia, Ospedale San Giuseppe
Milan, , Italy
UO epatologia, Istituto scientifico universitario San Raffaele
Milan, , Italy
AOU di Modena- U.O. Gastroenterologia
Modena, , Italy
Struttura Complessa di Medicina ad Indirizzo Metabolico Nutrizionale, Dipartimento Ospedaliero di Medicina Interna
Modena, , Italy
Day Hospital e Ambulatorio di Epatoogia e Nutrizione Clinica, Fondazione Evangelica Villa Betania, Ospedale generale di Zona
Napoli, , Italy
Ospedale policlinico Federico II di Napoli
Napoli, , Italy
Università della Campania Luigi Vanvitelli di Napoli- Dipartimento di epato-gastroenterologia
Napoli, , Italy
UO medicina ed epatologia, Ospedale maggiore della carità
Novara, , Italy
UO di Gastroenterologia, Azienda ospedaliera di Padova
Padua, , Italy
UO di Medicina Interna, Azienda Ospedaliera di Padova
Padua, , Italy
UO gastroenterologia, Policlinico Paolo Giaccone
Palermo, , Italy
Malattie infettive ed epatologia, Azienda ospedaliero universitaria di Parma
Parma, , Italy
Day Hospital Internistico e ambulatorio di Epatologia, ASL Pescara
Pescara, , Italy
UO epatologia, AOU pisana Cisanello
Pisa, , Italy
S.C. Gastroenterologia, Ospedale di Pordenone, AS FO
Pordenone, , Italy
Medicina clinica ed epatologia, Policlinico universitario campus bio-medico
Roma, , Italy
Policlinico Universitario Fondazione Agostino Gemelli- UO di medicina interna
Roma, , Italy
UO di Epatologia, Universita' di Roma Tor Vergata
Roma, , Italy
UO di Gastroenterologia, Policlinico Umberto I
Roma, , Italy
Medicina interna ed epatologia, Istituto clinico Humanitas
Rozzano, , Italy
Università degli studi di Salerno
Salerno, , Italy
SSD Epatologia, Fondazione Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
UO di Gastroenterologia e Endoscopia Digestiva, Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
Azienda Ospedale Universitaria di Sassari- UOC Medicina Interna
Sassari, , Italy
S.C. Gastroenterologia, Azienda Ospedaliero-Universitaria Molinette
Torino, , Italy
Gastroenterologia ed endoscopia digestiva, Azienda provinciale per i servizi sanitari
Trento, , Italy
Ospedale regionale Ca' Foncello di Treviso- Unità operativa complessa di Gastroenterologia
Treviso, , Italy
SC (UCO) Clinica Patologie del Fegato, Ospedale di Cattinara, ASU GI
Trieste, , Italy
SOS di DPT Epatologia e Trapianti di Fegato, ASU FC
Udine, , Italy
UO di gastroenterologia ed endoscopia digestiva, Azienda macchi, Asst sette laghi
Varese, , Italy
Azienda Ospedaliera Universitaria Integrata Verona- UOC Gastroeneterologia A
Verona, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PBC322
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.