Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-27 @ 11:06 PM
Study NCT ID:
NCT02616705
Status:
COMPLETED
Last Update Posted:
2022-01-05
First Post:
2015-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077733', 'term': 'Immunoglobulin G4-Related Disease'}], 'ancestors': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Bile'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 511}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-03', 'studyFirstSubmitDate': '2015-11-23', 'studyFirstSubmitQcDate': '2015-11-27', 'lastUpdatePostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ability of bile IgG4 concentration to distinguish between IgG4-SC, PSC, and CCA.', 'timeFrame': '2 year', 'description': 'Bile concentration of IgG4 will be measured in cases and controls, and the groups will be compared using appropriate statistical methods'}], 'secondaryOutcomes': [{'measure': 'Correlation between bile and serum IgG4 concentrations.', 'timeFrame': '2 years', 'description': 'The relationship between Bile and serum IgG4 concentrations will be assessed for case and controls, using appropriate statistical methods'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['IgG4-related Sclerosing Cholangitis', 'IgG4-related Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Immunoglobulin G4-related disease (IgG4-RD) is an uncommon inflammatory disorder that may affect multiple organ systems, including the biliary tree. IgG4-sclerosing cholangitis (IgG4-SC) can be difficult to distinguish from primary sclerosing cholangitis (PSC) or cholangiocarcinoma (CCA). The investigators aim to evaluate the sensitivity and specificity of bile for the diagnosis of IgG4-SC. Bile samples of patients with biliary strictures of various causes, including IgG4-SC, PSC, and CCA, will be collected during clinical cholangiography procedures. IgG4 will be measured in bile specimens and bile IgG4 concentrations compared between IgG4-SC, PSC, CCA, and other types of biliary strictures.', 'detailedDescription': 'This study will recruit cases from Mayo Clinic Rochester and Japanese institutions such as Nagoya City University Hospital, Nagoya Daini Red Cross Hospital, and Kurashiki Central hospital. Participants will be individuals who will receive endoscopic retrograde cholangiography (ERC), endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) or percutaneous transhepatic cholangiography (PTC). Bile samples collected from the target cases will be assayed for IgG4 concentration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cases with biliary stricture(s) of any cause', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The presence of a biliary stricture\n* 18 years and older\n* Consented to IRB 707-03\n\nExclusion Criteria:\n\n* Younger than 18 years of age\n* Unable to collect a bile sample\n* Abnormal postsurgical anatomy preventing collection of a bile sample'}, 'identificationModule': {'nctId': 'NCT02616705', 'briefTitle': 'Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis', 'orgStudyIdInfo': {'id': '15-004819'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IgG4-related sclerosing cholangitis', 'description': 'Patients with IgG4-related sclerosing cholangitis (also called IgG4 associated cholangitis, IgG4 related cholangitis, or biliary IgG4-related disease)'}, {'label': 'Controls', 'description': 'cholangiocarcinoma, PSC, and other patients with biliary strictures'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'city': 'Nagoya', 'country': 'Japan', 'facility': 'Nagoya City Universty Graduate School of Medical Sciences', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}], 'overallOfficials': [{'name': 'Lewis R Roberts, MB, ChB, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data sharing could be arranged and will require IRB approval'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nagoya University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lewis R. Roberts', 'investigatorAffiliation': 'Mayo Clinic'}}}}