Multicenter Observational Study of PSC and IgG4-SC in China

NCT05463445 | Unknown

• 1 other identifier: SC2022CH001
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Sclerosing Cholangitis; IgG4-related Sclerosing Cholangitis

Outcome Measures

Primary Outcomes (1)

• The percentage of new occurrence of decompensated liver related events, malignancies, liver transplantation and liver-related death caused by PSC and IgG4-SC

  describe the characteristics and clinical outcomes of PSC and IgG4-SC patients among multiple medical centers in China

  1 year

Study Arms (2)

A

patients diagnosed with Primary Sclerosing Cholangitis 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.

Other: Only observation

B

patients diagnosed with IgG4-related Sclerosing Cholangitis which met initially using the Japan Pancreas Society criteria and confirmed using HISORt criteria.

Other: Only observation

Interventions

Only observation OTHER

No intervention is needed.

A; B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This program will be conducted in multiple medical centers among the major cities across Mainland China. The sample size of subjects will be 1000, including 500 patients with PSC and 500 patients with IgG4-SC.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

RenJi Hospital

Shanghai, Shanghai Municipality, 200001, China

RECRUITING

MeSH Terms

Conditions

Cholangitis, Sclerosing

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Central Study Contacts

Min Lian, MD, PhD

CONTACT

+8615800744783; sophialian24@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 19, 2022
• Study Start: July 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: July 31, 2023
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)