[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03445585":3,"trial-entities:NCT03445585":96,"trial-summary:NCT03445585":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":31,"secondary_outcomes":35,"sex":42,"minimum_age":43,"maximum_age":44,"healthy_volunteers":45,"eligibility_criteria":46,"std_ages":63,"locations":66,"central_contacts":84,"overall_officials":91,"references":94,"see_also_links":95},"NCT03445585","16-005892","Biobank for Cholestatic Liver Diseases.","A Resource of Blood and Other Biospecimens of Patients With Cholestatic Liver Disease and Unaffected Individuals","RECRUITING","2050-01","2026-02","2026-02-17","2017-01","Mayo Clinic","OTHER",false,"This study is a biobank of specimens and clinical data for use in current and future research to better understand the cholestatic liver diseases primary biliary cirrhosis\u002Fcholangitis (PBC) and primary sclerosing cholangitis (PSC).","This study is a biobank of specimens and clinical data for use in current and future research to better understand the cholestatic liver diseases primary biliary cirrhosis\u002Fcholangitis (PBC) and primary sclerosing cholangitis (PSC).\n\nBlood, saliva, stool, and urine samples will be collected periodically during patient visits, mail-home kit (collected locally), or via remote phlebotomy at a place directed by the subject. Bile and bile duct cells will be collected during clinically necessary Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures being performed at Mayo Clinic for clinical reasons. Anticipated research will focus on multi-omics assessments of biospecimens to better define how these diseases start and progress in order to develop novel tests for early detection of complication and better disease prognostication.",[19,20,21,22],"Primary Sclerosing Cholangitis","Primary Biliary Cirrhosis","Cholangiocarcinoma","Liver Cancer",[],"OBSERVATIONAL",null,[],{"count":28,"type":29},9150,"ESTIMATED",[],[32],{"measure":33,"description":33,"timeFrame":34},"Number of participants in the study.","20 years",[36,39],{"measure":37,"description":38,"timeFrame":34},"Number of samples collected (per type).","Number of samples collected (blood, urine, stool, bile, bile duct cells)",{"measure":40,"description":41,"timeFrame":34},"Number of clinical phenotypes and\u002For endpoints observed (per category)","Number of clinical phenotypes and\u002For endpoints observed (i.e. disease progression, liver cancer development)","ALL","18 Years","85 Years",true,{"inclusion":47,"exclusion":50,"raw_text":62},[48,49],"Patients diagnosed with PSC and who are between the age of 18 and 85 at time of enrollment in the study.","The diagnosis of PSC will be based on standard PSC criteria including clinical and biochemical evidence of chronic cholestasis of at least six months duration, positive cholangiographic findings, and compatible liver biopsies if available.",[51,52,53,54,55,56,57,58,59,60,61],"Women with PSC of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation.","Patients diagnosed with PBC and who are between the age of 18 and 85 at time of enrollment in the study.","The diagnosis of PBC will be based on standard PBC criteria including clinical and biochemical evidence of chronic cholestasis of at least six month duration, positive anti-mitochondrial antibodies in serum and compatible liver biopsies, if available.","Women with PBC of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation.","Controls without history of PBC, PSC, or evidence of other chronic liver disease of either gender that participate in this study will be between the ages of 18 and 85.","Patients without history of PBC or PSC but do have evidence of other chronic liver disease of either gender will be offered participation in this study if between the ages of 18 and 85.","PBC or PSC patients with known and overlapping other chronic liver diseases","Patients unable to provide informed consent","Prisoners and institutionalized individuals","PSC with orthotopic liver transplantation","History of Roux en Y","Inclusion Criteria:\n\nPSC\n\n* Patients diagnosed with PSC and who are between the age of 18 and 85 at time of enrollment in the study.\n* The diagnosis of PSC will be based on standard PSC criteria including clinical and biochemical evidence of chronic cholestasis of at least six months duration, positive cholangiographic findings, and compatible liver biopsies if available.\n* Patients with PSC who have undergone orthotopic liver transplantation will be offered enrollment except for collection of bile - please see below under Exclusion Criteria.\n* Women with PSC of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation.\n\nPBC\n\n* Patients diagnosed with PBC and who are between the age of 18 and 85 at time of enrollment in the study.\n* The diagnosis of PBC will be based on standard PBC criteria including clinical and biochemical evidence of chronic cholestasis of at least six month duration, positive anti-mitochondrial antibodies in serum and compatible liver biopsies, if available.\n* Patients with PBC who have undergone orthotopic liver transplantation will be offered enrollment except for collection of bile - please see below under Exclusion Criteria.\n* Women with PBC of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation.\n\nControls\n\n* Controls without history of PBC, PSC, or evidence of other chronic liver disease of either gender that participate in this study will be between the ages of 18 and 85.\n\nLiver Disease Controls\n\n* Patients without history of PBC or PSC but do have evidence of other chronic liver disease of either gender will be offered participation in this study if between the ages of 18 and 85.\n\nExclusion Criteria (all subjects):\n\n* PBC or PSC patients with known and overlapping other chronic liver diseases\n* Patients unable to provide informed consent\n* Prisoners and institutionalized individuals\n\nExclusion Criteria (for bile collection during ERCP)\n\n* PSC with orthotopic liver transplantation\n* History of Roux en Y",[64,65],"ADULT","OLDER_ADULT",[67],{"facility":13,"status":8,"city":68,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":81},"Rochester","Minnesota","55901","United States",[73,78],{"name":74,"role":75,"phone":76,"email":77},"Erik M Schlicht, CCRP","CONTACT","507-284-4312","schlicht.erik@mayo.edu",{"name":79,"role":80},"Konstantinos N Lazaridis, M.D.","PRINCIPAL_INVESTIGATOR",{"lat":82,"lon":83},44.02163,-92.4699,[85,87],{"name":86,"role":75,"phone":76,"email":77},"Erik Schlicht, CCRP, B.A.",{"name":88,"role":75,"phone":89,"email":90},"Jackie Bianchi","507-266-0346","bianchi.jackie@mayo.edu",[92],{"name":93,"affiliation":13,"role":80},"Konstantinos Lazaridis, M.D.",[],[],{"nct_id":4,"conditions":97,"biomarkers":99},[21,98,20,19],"Liver Carcinoma",[100],"Caspase-3",{"nct_id":4,"found":45,"summary":102,"prompt_version":112},{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is an observational study, meaning researchers will collect information without giving any specific treatments. It plans to include 9150 participants.","completed","Biobank for Cholestatic Liver Diseases","This study is creating a collection of samples and health information, called a biobank, to help researchers better understand cholestatic liver diseases like primary biliary cirrhosis\u002Fcholangitis (PBC) and primary sclerosing cholangitis (PSC). The goal is to learn how these diseases start and progress, which could lead to new ways to detect complications early and predict how the disease will develop. You may be able to join if you are between 18 and 85 years old and have been diagnosed with PSC based on standard criteria, including signs of chronic cholestasis and specific findings from imaging tests. This study aims to enroll 9150 participants over 20 years.","Participants will be part of the study for 20 years, as the primary endpoint measures the number of participants over this time.",106,"Blood, saliva, stool, and urine samples will be collected periodically during your clinic visits, through mail-home kits, or by a remote phlebotomist. If you have an ERCP (Endoscopic Retrograde Cholangiopancreatography) procedure at Mayo Clinic for clinical reasons, bile and bile duct cells will also be collected.","Not stated in the trial record.",[],"v2"]