National Registry of IgG4-RD in China

January 23, 2017 updated by: Wen Zhang, Peking Union Medical College Hospital

The aim of this study is to establish a nation-wide cohort study of IgG4-related disease (IgG4-RD) in China.

Methods: All the patients fulfilling diagnostic criteria of IgG4-RD (2011) would be enrolled from multi-centers around China. A online database system has been established.

Endpoints: The primary endpoint is to investigate the clinical manifestations of Chinese IgG4-RD patients; the secondary endpoints including the demographic features,laboratory characteristics, immunological tests, imaging and pathological features, in addition, the treatment and prognosis of the disease.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This is a multicenter registry study of IgG4-RD patients. Newly diagnosed IgG4-RD patients will be recruited from allover the China. Inclusion criteria: patients with definite, probable, or possible IgG4-RD according to the 2011 comprehensive diagnostic criteria for IgG4-RD will be recruited. Exclusion criteria: patients with malignancy or other autoimmune diseases are excluded.

The data will be uploaded through the platform of Chinese Rheumatology Information Platform. Demographic data, initial symptoms, disease duration, history of allergy, and physical examination, organ involvements, laboratory findings, radiological and pathological results, as well as treatment, side effects will be recorded.

This study was approved by the Medical Ethics Committee of PUMCH (Beijing, China). All patients will signe informed consent.

Statistical Analysis: All parameters are described in the standard summary statistics, including mean, standard deviation, minimum, and maximum. All statistical analyses will be performed by SPSS.

Endpoints: The primary endpoint is to investigate the organ involvements of Chinese IgG4-RD patients. The secondary endpoints including the demographic features,laboratory characteristics, immunological tests, imaging and pathological features, in addition, the treatment and prognosis of the disease.

Study Type

Observational

Enrollment (Anticipated)

900

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
    • Beijing
      • Beijing, Beijing, China, 100032
        • Recruiting
        • Peking Union Medical College 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

IgG4-RD patients around China

Description

Inclusion Criteria:

  • Conforming to the diagnostic criteria of IgG4-RD (2011);

Exclusion Criteria:

  • Excluding other mimicing IgG4-RD, including tumors, vasculitis and sarcoidosis.

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: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Organ involvements of Chinese IgG4-RD patients
Time Frame: 5 years
To calculate the percentage of organ involvements in at least 900 patients.
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rate of glucocorticoids and immunosuppressants on IgG4-RD in China
Time Frame: 5 years
5 years
Relapse rate of IgG4-RD patients in China
Time Frame: 5 years
5 years
The correlation between baseline disease activities and relapse rate.
Time Frame: 5 years
5 years
The incidence rate of tumor in IgG4 related disease patients in China.
Time Frame: 5 years
5 years
Ten year survival rate of patients with IgG4 related disease in China.
Time Frame: 10 years
10 years
The imaging features of involved organs.
Time Frame: 3 years
3 years
The sensitivity and specificity of IgG4 positive plasma cells in pathological diagnosis of IgG4 related disease.
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

Peking Union Medical College Hospital

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

December 1, 2016

Primary Completion (Anticipated)

December 1, 2026

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

January 2, 2017

First Submitted That Met QC Criteria

January 14, 2017

First Posted (Estimate)

January 18, 2017

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IgG4-RD Group in China

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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