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Multicenter Observational Study of PSC and IgG4-SC in China

Multicenter Study of Clinical Characteristics and Management of Primary Sclerosing Cholangitis and IgG4-related Sclerosing Cholangitis in China.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05463445
Enrollment
1000
Registered
2022-07-19
Start date
2022-07-01
Completion date
2023-07-31
Last updated
2022-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgG4-related Sclerosing Cholangitis, Primary Sclerosing Cholangitis

Brief summary

The investigators aimed to collect demographic features and clinical outcomes in patients diagnosed with PSC and IgG4-SC by utilizing participants database from multiple medical centers across Mainland China. Cross-sectional studies will focus on characterizing clinical presentations and validating diagnostic and prognostic models on Chinese PSC and IgG4-SC patients.

Interventions

No intervention is needed.

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Age above 18 years old, * Male or Female, * Patients admitted in our medical centers which met the PSC criteria according to The European Association for the Study of the Liver Clinical Practice Guidelines Management of cholestatic liver diseases in 2009; or patients diagnosed with IgG4-SC which met initially using the Japan Pancreas Society criteria and confirmed using HISORt criteria.

Exclusion criteria

* Female subjects who is pregnant, breastfeeding or is considering being pregnant during the study; * History of other malignancies, including hematological tumors, solid tumors except hepatobiliary system; * History of infectious diseases, including hepatis A, B, C, E and tuberculosis.

Design outcomes

Primary

MeasureTime frameDescription
The percentage of new occurrence of decompensated liver related events, malignancies, liver transplantation and liver-related death caused by PSC and IgG4-SC1 yeardescribe the characteristics and clinical outcomes of PSC and IgG4-SC patients among multiple medical centers in China

Countries

China

Contacts

Primary ContactMin Lian, MD, PhD
sophialian24@163.com+8615800744783

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026