National Registry of IgG4-RD in China
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: IgG4-Related Disease. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- Organ involvements of Chinese IgG4-RD patients [Time frame: 5 years]
Secondary outcome measures (7)
- Response rate of glucocorticoids and immunosuppressants on IgG4-RD in China [Time frame: 5 years]
- Relapse rate of IgG4-RD patients in China [Time frame: 5 years]
- The correlation between baseline disease activities and relapse rate. [Time frame: 5 years]
- The incidence rate of tumor in IgG4 related disease patients in China. [Time frame: 5 years]
- Ten year survival rate of patients with IgG4 related disease in China. [Time frame: 10 years]
- The imaging features of involved organs. [Time frame: 3 years]
- The sensitivity and specificity of IgG4 positive plasma cells in pathological diagnosis of IgG4 related disease. [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Conforming to the diagnostic criteria of IgG4-RD (2011);
Exclusion criteria
- Excluding other mimicing IgG4-RD, including tumors, vasculitis and sarcoidosis.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT03023371 · IgG4-RD Group in China