Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT01670695
Status:
RECRUITING
Last Update Posted:
2017-04-11
First Post:
2012-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Cohort Study of IgG4RD in China
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': 'SAMPLES_WITH_DNA', 'description': 'blood samples (serum and plasma, with DNA)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2032-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-07', 'studyFirstSubmitDate': '2012-08-16', 'studyFirstSubmitQcDate': '2012-08-20', 'lastUpdatePostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2032-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Response', 'timeFrame': '6 months', 'description': 'Clinical Response is measured by IgG4-RD Responder Index, including organ/site score and serum IgG4 level.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IgG4-related disease', 'IgG4-RD'], 'conditions': ['IgG4-related Disease']}, 'referencesModule': {'references': [{'pmid': '32733900', 'type': 'DERIVED', 'citation': 'Luo X, Peng Y, Zhang P, Li J, Liu Z, Lu H, Zhang X, Zeng X, Zhang F, Fei Y, Zhang W. Comparison of the Effects of Cyclophosphamide and Mycophenolate Mofetil Treatment Against Immunoglobulin G4-Related Disease: A Retrospective Cohort Study. Front Med (Lausanne). 2020 Jul 7;7:253. doi: 10.3389/fmed.2020.00253. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'This is an cohort study to investigate the disease course and treatment response of patients with IgG4-related disease.', 'detailedDescription': 'Immunoglobulin G4-related disease (IgG4-RD) is a recently defined emerging clinical entity characterized by tissue infiltration by IgG4-positive plasma cells, tissue fibrosclerosis and elevated serum IgG4 concentration.\n\nIn this study, patients with IgG4-RD will be investigated, including clinical presentation, laboratory findings and imaging study. All patients will be treated by standard care and follow-uped for at least 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with newly diagnosed IgG4-related disease.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females\n* Age 18-75 years old with informed consent\n* Patients with IgG4-RD:\n\n 1. swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions;\n 2. elevated serum IgG4 (\\>1.35 g/L)\n 3. histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed);\n 4. exclusion of other diseases.\n\nExclusion Criteria:\n\n* Females planning to bear a child recently or with childbearing potential\n* Concurrent severe and/or uncontrolled and/or unstable diseases\n* Patient with malignancy'}, 'identificationModule': {'nctId': 'NCT01670695', 'briefTitle': 'A Prospective Cohort Study of IgG4RD in China', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Cohort Study of Patients With IgG4-Related Disease', 'orgStudyIdInfo': {'id': 'IgG4RD-Cohort'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IgG4-RD', 'description': "Patients with IgG4-RD, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis (Mikulicz disease and Küttner's tumor), inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions."}]}, 'contactsLocationsModule': {'locations': [{'zip': '100032', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wen Zhang, MD', 'role': 'CONTACT', 'email': 'zhangwen91@sina.com', 'phone': '86-10-69158795'}, {'name': 'Hua Chen, MD', 'role': 'CONTACT', 'email': 'chen77hua@gmail.com', 'phone': '86-10-69158797'}], 'facility': 'Deptment of Rheumatology, Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Hua Chen, MD', 'role': 'CONTACT', 'email': 'chen77hua@gmail.com', 'phone': '86-10-69158797'}], 'overallOfficials': [{'name': 'Wen Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Deptment of Rheumatology, Peking Union Medical College Hospital'}, {'name': 'Fengchun Zhang', 'role': 'STUDY_CHAIR', 'affiliation': 'Deptment of Rheumatology, Peking Union Medical College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Wen Zhang', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}