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According to well-established criteria, PBC is diagnosed in subjects who fulfill two of the three of following criteria:\n\n1. elevated alkaline phosphatase and \u002For GGT;\n2. positive anti-mitochondrial autoantibodies (titer ≥ 1:40) or PBC-specific antinuclear antibodies (gp-210 and sp100);\n3. characteristic histological features of florid bile ducts lesions and granulomatous lesion.",[13],"Other: Clinical information",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Clinical information","The investigators will recruit PBC patients and collect important clinical information and laboratory investigation, together with biological samples.",[9],[20,21],"Laboratory information","Biological samples",[23,28],{"name":24,"role":25,"phone":26,"phoneExt":10,"email":27},"Pietro Invernizzi, MD","CONTACT","+39 039 233 2187","pietro.invernizzi@unimib.it",{"name":29,"role":25,"phone":30,"phoneExt":10,"email":31},"Marco Carbone, MD","02 6448 8139","marco.carbone@unimib.it",[33,44,52,60,72,78,86,94,99,107,115,123,131,139,147,155,163,171,179,187,195,203,219,226,231,236,241,249,254,262,267,272,280,288,293,301,309,317,325,333,341,346,351,356,364,372,380,385,393,401,409,417,425,433,441],{"facility":34,"status":35,"city":36,"state":10,"zip":10,"country":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":10},"Ospedali riuniti di Ancona","RECRUITING","Ancona","Italy",{"type":39,"coordinates":40},"Point",[41,42],13.5103,43.60717,{"lat":42,"lon":41},{"facility":45,"status":35,"city":46,"state":10,"zip":10,"country":37,"cosmosGeoPoint":47,"geoPoint":51,"contacts":10},"A.O.U. 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Centro Universitario per la ricerca e la Cura delle Malattie Epatiche","Foggia",{"type":39,"coordinates":167},[168,169],15.55188,41.45845,{"lat":169,"lon":168},{"facility":172,"status":35,"city":173,"state":10,"zip":10,"country":37,"cosmosGeoPoint":174,"geoPoint":178,"contacts":10},"Ambulatorio di Malattie del Fegato, U.O. Medicina, ASST Valle Olona, Presidio di Gallarate","Gallarate",{"type":39,"coordinates":175},[176,177],8.79164,45.66019,{"lat":177,"lon":176},{"facility":180,"status":35,"city":181,"state":10,"zip":10,"country":37,"cosmosGeoPoint":182,"geoPoint":186,"contacts":10},"UO Clinica Gastroenterologica, Policlinico San Martino","Genova",{"type":39,"coordinates":183},[184,185],11.87211,45.21604,{"lat":185,"lon":184},{"facility":188,"status":35,"city":189,"state":10,"zip":10,"country":37,"cosmosGeoPoint":190,"geoPoint":194,"contacts":10},"Centro Medicina del Viaggiatore e delle Migrazioni, ASP Catanzaro, Presìdio Ospedaliero \"Giovanni Paolo II\"","Lamezia Terme",{"type":39,"coordinates":191},[192,193],16.30938,38.96255,{"lat":193,"lon":192},{"facility":196,"status":74,"city":197,"state":10,"zip":10,"country":37,"cosmosGeoPoint":198,"geoPoint":202,"contacts":10},"UO di epatologia clinica e biomolecolare, Università degli studi di Messina","Messina",{"type":39,"coordinates":199},[200,201],15.55256,38.19394,{"lat":201,"lon":200},{"facility":204,"status":35,"city":205,"state":10,"zip":206,"country":37,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"University of Milano-Bicocca","Milan","20126",{"type":39,"coordinates":208},[209,210],9.18951,45.46427,{"lat":210,"lon":209},[213,215,217],{"name":214,"role":25,"phone":10,"phoneExt":10,"email":27},"Pietro Invernizzi",{"name":216,"role":25,"phone":10,"phoneExt":10,"email":31},"Marco Carbone",{"name":214,"role":218,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"facility":220,"status":35,"city":205,"state":10,"zip":10,"country":37,"cosmosGeoPoint":221,"geoPoint":225,"contacts":10},"Policlinico di Milano",{"type":39,"coordinates":222},[223,224],12.59836,42.78235,{"lat":224,"lon":223},{"facility":227,"status":35,"city":205,"state":10,"zip":10,"country":37,"cosmosGeoPoint":228,"geoPoint":230,"contacts":10},"UO di epatologia, Ospedale Niguarda Ca' Granda",{"type":39,"coordinates":229},[223,224],{"lat":224,"lon":223},{"facility":232,"status":35,"city":205,"state":10,"zip":10,"country":37,"cosmosGeoPoint":233,"geoPoint":235,"contacts":10},"UO di Epatologia, Ospedale San Giuseppe",{"type":39,"coordinates":234},[223,224],{"lat":224,"lon":223},{"facility":237,"status":35,"city":205,"state":10,"zip":10,"country":37,"cosmosGeoPoint":238,"geoPoint":240,"contacts":10},"UO epatologia, Istituto scientifico universitario San Raffaele",{"type":39,"coordinates":239},[223,224],{"lat":224,"lon":223},{"facility":242,"status":35,"city":243,"state":10,"zip":10,"country":37,"cosmosGeoPoint":244,"geoPoint":248,"contacts":10},"AOU di Modena- U.O. 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Gastroenterologia, Ospedale di Pordenone, AS FO","Pordenone",{"type":39,"coordinates":329},[330,331],12.66051,45.95689,{"lat":331,"lon":330},{"facility":334,"status":35,"city":335,"state":10,"zip":10,"country":37,"cosmosGeoPoint":336,"geoPoint":340,"contacts":10},"Medicina clinica ed epatologia, Policlinico universitario campus bio-medico","Roma",{"type":39,"coordinates":337},[338,339],11.10642,44.99364,{"lat":339,"lon":338},{"facility":342,"status":35,"city":335,"state":10,"zip":10,"country":37,"cosmosGeoPoint":343,"geoPoint":345,"contacts":10},"Policlinico Universitario Fondazione Agostino Gemelli- UO di medicina interna",{"type":39,"coordinates":344},[338,339],{"lat":339,"lon":338},{"facility":347,"status":35,"city":335,"state":10,"zip":10,"country":37,"cosmosGeoPoint":348,"geoPoint":350,"contacts":10},"UO di Epatologia, Universita' di Roma Tor Vergata",{"type":39,"coordinates":349},[338,339],{"lat":339,"lon":338},{"facility":352,"status":35,"city":335,"state":10,"zip":10,"country":37,"cosmosGeoPoint":353,"geoPoint":355,"contacts":10},"UO di Gastroenterologia, Policlinico Umberto I",{"type":39,"coordinates":354},[338,339],{"lat":339,"lon":338},{"facility":357,"status":35,"city":358,"state":10,"zip":10,"country":37,"cosmosGeoPoint":359,"geoPoint":363,"contacts":10},"Medicina interna ed epatologia, Istituto clinico Humanitas","Rozzano",{"type":39,"coordinates":360},[361,362],9.1559,45.38193,{"lat":362,"lon":361},{"facility":365,"status":35,"city":366,"state":10,"zip":10,"country":37,"cosmosGeoPoint":367,"geoPoint":371,"contacts":10},"Università degli studi di Salerno","Salerno",{"type":39,"coordinates":368},[369,370],14.79328,40.67545,{"lat":370,"lon":369},{"facility":373,"status":74,"city":374,"state":10,"zip":10,"country":37,"cosmosGeoPoint":375,"geoPoint":379,"contacts":10},"SSD Epatologia, Fondazione Casa Sollievo della Sofferenza","San Giovanni Rotondo",{"type":39,"coordinates":376},[377,378],15.7277,41.70643,{"lat":378,"lon":377},{"facility":381,"status":35,"city":374,"state":10,"zip":10,"country":37,"cosmosGeoPoint":382,"geoPoint":384,"contacts":10},"UO di Gastroenterologia e Endoscopia Digestiva, Ospedale Casa Sollievo della Sofferenza",{"type":39,"coordinates":383},[377,378],{"lat":378,"lon":377},{"facility":386,"status":35,"city":387,"state":10,"zip":10,"country":37,"cosmosGeoPoint":388,"geoPoint":392,"contacts":10},"Azienda Ospedale Universitaria di Sassari- UOC Medicina Interna","Sassari",{"type":39,"coordinates":389},[390,391],8.55552,40.72586,{"lat":391,"lon":390},{"facility":394,"status":35,"city":395,"state":10,"zip":10,"country":37,"cosmosGeoPoint":396,"geoPoint":400,"contacts":10},"S.C. Gastroenterologia, Azienda Ospedaliero-Universitaria Molinette","Torino",{"type":39,"coordinates":397},[398,399],11.99138,44.88856,{"lat":399,"lon":398},{"facility":402,"status":35,"city":403,"state":10,"zip":10,"country":37,"cosmosGeoPoint":404,"geoPoint":408,"contacts":10},"Gastroenterologia ed endoscopia digestiva, Azienda provinciale per i servizi sanitari","Trento",{"type":39,"coordinates":405},[406,407],11.12108,46.06787,{"lat":407,"lon":406},{"facility":410,"status":35,"city":411,"state":10,"zip":10,"country":37,"cosmosGeoPoint":412,"geoPoint":416,"contacts":10},"Ospedale regionale Ca' Foncello di Treviso- Unità operativa complessa di Gastroenterologia","Treviso",{"type":39,"coordinates":413},[414,415],12.2416,45.66673,{"lat":415,"lon":414},{"facility":418,"status":35,"city":419,"state":10,"zip":10,"country":37,"cosmosGeoPoint":420,"geoPoint":424,"contacts":10},"SC (UCO) Clinica Patologie del Fegato, Ospedale di Cattinara, ASU GI","Trieste",{"type":39,"coordinates":421},[422,423],13.77678,45.64953,{"lat":423,"lon":422},{"facility":426,"status":35,"city":427,"state":10,"zip":10,"country":37,"cosmosGeoPoint":428,"geoPoint":432,"contacts":10},"SOS di DPT Epatologia e Trapianti di Fegato, ASU FC","Udine",{"type":39,"coordinates":429},[430,431],13.23715,46.0693,{"lat":431,"lon":430},{"facility":434,"status":35,"city":435,"state":10,"zip":10,"country":37,"cosmosGeoPoint":436,"geoPoint":440,"contacts":10},"UO di gastroenterologia ed endoscopia digestiva, Azienda macchi, Asst sette laghi","Varese",{"type":39,"coordinates":437},[438,439],8.82511,45.82058,{"lat":439,"lon":438},{"facility":442,"status":35,"city":443,"state":10,"zip":10,"country":37,"cosmosGeoPoint":444,"geoPoint":448,"contacts":10},"Azienda Ospedaliera Universitaria Integrata Verona- UOC Gastroeneterologia A","Verona",{"type":39,"coordinates":445},[446,447],10.9938,45.43854,{"lat":447,"lon":446},{"type":450,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100450923",false,"NCT05151809","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","PBC322","Inclusion Criteria:\n\nAll 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:\n\n* elevated alkaline phosphatase and \u002For GGT;\n* positive anti-mitochondrial autoantibodies (titer ≥ 1:40) or PBC-specific antinuclear antibodies (gp-210 and sp100);\n* characteristic histological features of florid bile ducts lesions and granulomatous lesion.\n\nExclusion Criteria:\n\nThe patient has explicitly declared his\u002Fher unwillingness to participate to the study","ALL","18 Years",{"count":461,"type":462},6000,"ESTIMATED","10 Years","OBSERVATIONAL","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.",[467],"Primary Biliary Cholangitis",[467,469,470],"Disease phenotypes","National Database","2025-07-24",{"date":473,"type":474},"2025-07-25","ACTUAL",{"date":476,"type":474},"2019-09-19",{"date":478,"type":462},"2029-01-24",{"name":5,"class":6},55]