Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital

November 7, 2020 updated by: Xiaoli Fan
Retrospective study of all patients diagnosed with primary biliary cholangitis during January 2001 to July 2016 at West China Hospital by review of medical records. The following variables will be retrospectively studied: age, sex, first symptoms, clinical characteristics, pathology, treatment, stage, complications of cirrhosis, other autoimmune diseases and long-term outcome.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

769

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients diagnosed with primary biliary cholangitis during January 2001 to July 2016 at West China Hospital by review of medical records.

Description

Inclusion Criteria:

  • Newly diagnosis of PBC at West China Hospital during January 2001 to July 2016.

Exclusion Criteria:

  • Simultaneously diagnosed of autoimmune hepatitis or primary sclerosing cholangitis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Primary biliary cholangitis during January 2001 to July 2016

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Description of demographics, management patterns (clinical and diagnostic), comorbidities of PBC patients at diagnosis during the past 16 years.
Time Frame: Up to 16 years.
Up to 16 years.

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of adverse outcome free survival of the PBC cohort during the 16 years.
Time Frame: Up to 16 years.
Up to 16 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiaoli Fan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

September 6, 2016

First Submitted That Met QC Criteria

September 26, 2016

First Posted (Estimate)

September 28, 2016

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 7, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBC-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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