NCT04981756

PSC Clinical Epidemiology in China

Primary Sclerosing Cholangitis in China: Epidemiology, Cascade and Treatment

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Beijing Friendship Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Primary Sclerosing Cholangitis

Interventions

Type	Name	Description
OTHER	observation	This observational study does not have any intervention.

Timeline

• Start date: 2021-04-07
• Primary completion: 2023-06-01
• Completion: 2023-12-01
• First posted: 2021-07-29
• Last updated: 2023-05-26

Locations

3 sites across 1 country: China