Multicenter Observational Study of PSC and IgG4-SC in China

NCT ID: NCT05463445

Last Updated: 2022-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Sclerosing Cholangitis IgG4-related Sclerosing Cholangitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Only observation

Intervention Type OTHER

No intervention is needed.

B

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

Only observation

Intervention Type OTHER

No intervention is needed.

Interventions

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Only observation

No intervention is needed.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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ma xiong

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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RenJi Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Min Lian, MD, PhD

Role: CONTACT

+8615800744783

Facility Contacts

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Min Lian, MD, PhD

Role: primary

+8615800744783

Other Identifiers

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SC2022CH001

Identifier Type: -

Identifier Source: org_study_id

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