Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beijing YouAn Hospital | OTHER |
| Shanghai Suvalue Health Scientific Ltd. | UNKNOWN |
| The First Hospital of Jilin University | OTHER |
| Beijing Ditan Hospital |
Not provided
Not provided
Not provided
Not provided
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.
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.
Collect 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| observation | Other | This observational study does not have any intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| The prevalence of PSC | The crude prevalence of PSC patients | 7 years |
| Crowd Distribution of PSC in China | Crowd distribution includes the age-specified/sex-specified distribution | 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| The positive rate of ANCA | The percentage of patients with anti-neutrophil cytoplasmic antibodies (ANCA) positive | 0 to 7 years |
| Dynamic changes of aminotransferase | Dynamic changes of alanine aminotransferase (ALT) from year-0 to year-7 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jidong Jia, MD, PhD | Beijing Friendship Hospital, Capital Medical University, Beijing, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical Univeristy | Beijing | Beijing Municipality | 100050 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29574971 | Background | 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. | |
| 23686586 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015209 | Cholangitis, Sclerosing |
| ID | Term |
|---|---|
| D002761 | Cholangitis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
Not provided
Not provided
| OTHER |
| Tianjin Medical University General Hospital | OTHER |
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
| Second Hospital of Jilin University | OTHER |
| Hepatobiliary Disease Hospital of Jilin Province | UNKNOWN |
| Lanzhou University Second Hospital | OTHER |
| First Affiliated Hospital of Xinjiang Medical University | OTHER |
Not provided
Not provided
Not provided
| 0 to 7 years |
| Dynamic changes of aspartate aminotransferase | Dynamic changes of aspartate aminotransferase (AST) from year-0 to year-7 | 0 to 7 years |
| Dynamic changes of alkaline phosphatase | Dynamic changes of alkaline phosphatase (ALP) from year-0 to year-7 | 0 to 7 years |
| Dynamic changes of gamma-glutamyl transpeptidase | Dynamic changes of gamma-glutamyl transpeptidase (GGT) from year-0 to year-7 | 0 to 7 years |
| Dynamic changes of serum total bilirubin | Dynamic changes of serum total bilirubin (TBIL) from year-0 to year-7 | 0 to 7 years |
| Dynamic changes of the radiological features measured by Magnetic Resonance Cholangiopancreatography (MRCP) or Encoscopic Retrograde Cholangio-Pancreatography (ERCP) | Dynamic changes of the radiological features at baseline and after 1, 3, 5, 7 years of treatment | 0 to 7 years |
| Incidence of concomitant diseases | Concomitant diseases include IBD (UC or CD), AIH, PBC, cirrhosis, cholelithiasis or cholangiocarcinoma | 0 to 7 years |
| Cumulative incidence of clinical outcomes | Cumulative incidence of liver decompensation (including ascites, hepatic encephalopathy, esophageal varices bleeding and Hepatocellular Carcinoma) , liver transplantation, cholangiocarcinoma and death | 0 to 7 years |
| The medication information | Document medication information from year-0 to year-7 | 0 to 7 years |
| Beijing Youan Hospital, Capital Medical University |
| Beijing |
| Beijing Municipality |
| 100054 |
| China |
| Shanghai Suvalue Health Scientific Ltd. | Shanghai | Shanghai Municipality | 200032 | China |
| 23775876 | Background | 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. |
| 9089907 | Background | 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. |
| 27891750 | Background | 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. |
| 30742832 | Background | 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. |
| 30815073 | Background | 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. |
| 23929403 | Background | 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. |