Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-31 @ 2:07 AM
Study NCT ID:
NCT04981756
Status:
UNKNOWN
Last Update Posted:
2023-05-26
First Post:
2021-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PSC Clinical Epidemiology in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015209', 'term': 'Cholangitis, Sclerosing'}], 'ancestors': [{'id': 'D002761', 'term': 'Cholangitis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-25', 'studyFirstSubmitDate': '2021-06-23', 'studyFirstSubmitQcDate': '2021-07-27', 'lastUpdatePostDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The prevalence of PSC', 'timeFrame': '7 years', 'description': 'The crude prevalence of PSC patients'}, {'measure': 'Crowd Distribution of PSC in China', 'timeFrame': '7 years', 'description': 'Crowd distribution includes the age-specified/sex-specified distribution'}], 'secondaryOutcomes': [{'measure': 'The positive rate of ANCA', 'timeFrame': '0 to 7 years', 'description': 'The percentage of patients with anti-neutrophil cytoplasmic antibodies (ANCA) positive'}, {'measure': 'Dynamic changes of aminotransferase', 'timeFrame': '0 to 7 years', 'description': 'Dynamic changes of alanine aminotransferase (ALT) from year-0 to year-7'}, {'measure': 'Dynamic changes of aspartate aminotransferase', 'timeFrame': '0 to 7 years', 'description': 'Dynamic changes of aspartate aminotransferase (AST) from year-0 to year-7'}, {'measure': 'Dynamic changes of alkaline phosphatase', 'timeFrame': '0 to 7 years', 'description': 'Dynamic changes of alkaline phosphatase (ALP) from year-0 to year-7'}, {'measure': 'Dynamic changes of gamma-glutamyl transpeptidase', 'timeFrame': '0 to 7 years', 'description': 'Dynamic changes of gamma-glutamyl transpeptidase (GGT) from year-0 to year-7'}, {'measure': 'Dynamic changes of serum total bilirubin', 'timeFrame': '0 to 7 years', 'description': 'Dynamic changes of serum total bilirubin (TBIL) from year-0 to year-7'}, {'measure': 'Dynamic changes of the radiological features measured by Magnetic Resonance Cholangiopancreatography (MRCP) or Encoscopic Retrograde Cholangio-Pancreatography (ERCP)', 'timeFrame': '0 to 7 years', 'description': 'Dynamic changes of the radiological features at baseline and after 1, 3, 5, 7 years of treatment'}, {'measure': 'Incidence of concomitant diseases', 'timeFrame': '0 to 7 years', 'description': 'Concomitant diseases include IBD (UC or CD), AIH, PBC, cirrhosis, cholelithiasis or cholangiocarcinoma'}, {'measure': 'Cumulative incidence of clinical outcomes', 'timeFrame': '0 to 7 years', 'description': 'Cumulative incidence of liver decompensation (including ascites, hepatic encephalopathy, esophageal varices bleeding and Hepatocellular Carcinoma) , liver transplantation, cholangiocarcinoma and death'}, {'measure': 'The medication information', 'timeFrame': '0 to 7 years', 'description': 'Document medication information from year-0 to year-7'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epidemiology', 'Cascade', 'Treatment'], 'conditions': ['Primary Sclerosing Cholangitis']}, 'referencesModule': {'references': [{'pmid': '29574971', 'type': 'BACKGROUND', 'citation': 'Ponsioen CY, Lindor KD, Mehta R, Dimick-Santos L. Design and Endpoints for Clinical Trials in Primary Sclerosing Cholangitis. Hepatology. 2018 Sep;68(3):1174-1188. doi: 10.1002/hep.29882. Epub 2018 Aug 31.'}, {'pmid': '23686586', 'type': 'BACKGROUND', 'citation': 'Deneau M, Jensen MK, Holmen J, Williams MS, Book LS, Guthery SL. Primary sclerosing cholangitis, autoimmune hepatitis, and overlap in Utah children: epidemiology and natural history. Hepatology. 2013 Oct;58(4):1392-400. doi: 10.1002/hep.26454. Epub 2013 Aug 13.'}, {'pmid': '23775876', 'type': 'BACKGROUND', 'citation': 'Boonstra K, Weersma RK, van Erpecum KJ, Rauws EA, Spanier BW, Poen AC, van Nieuwkerk KM, Drenth JP, Witteman BJ, Tuynman HA, Naber AH, Kingma PJ, van Buuren HR, van Hoek B, Vleggaar FP, van Geloven N, Beuers U, Ponsioen CY; EpiPSCPBC Study Group. Population-based epidemiology, malignancy risk, and outcome of primary sclerosing cholangitis. Hepatology. 2013 Dec;58(6):2045-55. doi: 10.1002/hep.26565. Epub 2013 Oct 17.'}, {'pmid': '9089907', 'type': 'BACKGROUND', 'citation': 'Metcalf J, James O. The geoepidemiology of primary biliary cirrhosis. Semin Liver Dis. 1997 Feb;17(1):13-22. doi: 10.1055/s-2007-1007179.'}, {'pmid': '27891750', 'type': 'BACKGROUND', 'citation': 'Liu K, Wang R, Kariyawasam V, Wells M, Strasser SI, McCaughan G, Corte C, Leong RW. Epidemiology and outcomes of primary sclerosing cholangitis with and without inflammatory bowel disease in an Australian cohort. Liver Int. 2017 Mar;37(3):442-448. doi: 10.1111/liv.13328. Epub 2017 Jan 24.'}, {'pmid': '30742832', 'type': 'BACKGROUND', 'citation': 'Shen T, Liu Y, Shang J, Xie Q, Li J, Yan M, Xu J, Niu J, Liu J, Watkins PB, Aithal GP, Andrade RJ, Dou X, Yao L, Lv F, Wang Q, Li Y, Zhou X, Zhang Y, Zong P, Wan B, Zou Z, Yang D, Nie Y, Li D, Wang Y, Han X, Zhuang H, Mao Y, Chen C. Incidence and Etiology of Drug-Induced Liver Injury in Mainland China. Gastroenterology. 2019 Jun;156(8):2230-2241.e11. doi: 10.1053/j.gastro.2019.02.002. Epub 2019 Feb 8.'}, {'pmid': '30815073', 'type': 'BACKGROUND', 'citation': 'Colbaugh R, Glass K, Rudolf C, Tremblay Volv Global Lausanne Switzerland M. Learning to Identify Rare Disease Patients from Electronic Health Records. AMIA Annu Symp Proc. 2018 Dec 5;2018:340-347. eCollection 2018.'}, {'pmid': '23929403', 'type': 'BACKGROUND', 'citation': 'Sada Y, Hou J, Richardson P, El-Serag H, Davila J. Validation of Case Finding Algorithms for Hepatocellular Cancer From Administrative Data and Electronic Health Records Using Natural Language Processing. Med Care. 2016 Feb;54(2):e9-14. doi: 10.1097/MLR.0b013e3182a30373.'}]}, 'descriptionModule': {'briefSummary': 'Primary sclerosing cholangitis (PSC) is a rare disease but is increasingly reported in China (mainly in the Chinese language). However, most of the PSC literatures reported from China are case reports, small case series, and review articles. Up to now, there is no information on the epidemiology and disease burden of PSC in China. This study would use EMR/HIS and research databases to investigate the epidemiology, cascade, and treatment pattern of PSC in China.', 'detailedDescription': "Identify the PSC cases diagnosed from the earliest date available to the present in the SuValue Research Database and the HIS/EMR from clinical sites through diagnostic ICD codes, laboratory, pathology, imaging, endoscopy, surgery, medication, hospitalization, and health outcomes.\n\nCollect information on PSC cases' key demographic, the time of PSC diagnosis, hematological/biochemical variables (ALT, AST, ALP, GGT, ALP TBil, ALB), MRCP or ERCP or pathological report, IBD (UC or CD) symptoms, or colon, medication information, clinical outcomes (including cirrhosis, decompensated cirrhosis, death or liver transplantation) as well as current or past treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Total number of subjects expected to be reviewed is 800. The subjects in this study will consist of two parts: identify PSC cases by retrospective review of an inter-regional database and retro-prospective review of EMR of two tertiary medical centers in Beijing.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Retrospectively review PSC cases before April 1, 2002 will be identified by diagnostic codes from the International Classification of Diseases (ICD)-9, and for those after April 1, 2002, we used ICD-10.\n2. We identified patients using an electronic search of SuValue Research Database and HIS of BFH-CMU and BYH-CMU using PSC related ICD codes (ICD-9: 576.1; ICD-10: K83.016/K83.016(China version)). To supplement the ICD search, an electronic keyword search for "primary sclerosing cholangitis" or "seclerosing cholangitis" was conducted on all radiology, endoscopy, pathology reports beginning on earliest date available in the database of SuValue Research Database and HIS of BFH-CMU and BYH-CMU. We reviewed the medical charts of identified patients and diagnostic criteria including cholestatic biochemistry (ALP, GGT elevations), and typical imaging (MRCP or ERCP) or pathological features, excluding other known etiology. For patients with multiple visits for PSC, we reviewed only the index visit. To ensure consistency, chart review was independently assessed by two hepatologists. Discrepancies in compliance were resolved by discussion between the two main reviewers. Any unresolved discrepancies were decided by a third expert hepatologist.\n\nExclusion Criteria:\n\n1. The cases with secondary sclerosing cholangitis caused by cholelithiasis, IgG4 related disease, malignancy or other known etiologies.\n2. The cases with missing key results on clinical, biochemical (ALP, GGT, bilirubin), radiological (MRCP or ERCP) or histological investigations.'}, 'identificationModule': {'nctId': 'NCT04981756', 'briefTitle': 'PSC Clinical Epidemiology in China', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Friendship Hospital'}, 'officialTitle': 'Primary Sclerosing Cholangitis in China: Epidemiology, Cascade and Treatment', 'orgStudyIdInfo': {'id': 'IN-CN-428-5940'}}, 'armsInterventionsModule': {'interventions': [{'name': 'observation', 'type': 'OTHER', 'description': 'This observational study does not have any intervention.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Friendship Hospital, Capital Medical Univeristy', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100054', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Youan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Suvalue Health Scientific Ltd.', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Jidong Jia, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Friendship Hospital, Capital Medical University, Beijing, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing YouAn Hospital', 'class': 'OTHER'}, {'name': 'Shanghai Suvalue Health Scientific Ltd.', 'class': 'UNKNOWN'}, {'name': 'The First Hospital of Jilin University', 'class': 'OTHER'}, {'name': 'Beijing Ditan Hospital', 'class': 'OTHER'}, {'name': 'Tianjin Medical University General Hospital', 'class': 'OTHER'}, {'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}, {'name': 'Second Hospital of Jilin University', 'class': 'OTHER'}, {'name': 'Hepatobiliary Disease Hospital of Jilin Province', 'class': 'UNKNOWN'}, {'name': 'Lanzhou University Second Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Xinjiang Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Liver Research Center', 'investigatorFullName': 'Jidong Jia', 'investigatorAffiliation': 'Beijing Friendship Hospital'}}}}