IgG4-Related Disease Clinical Trial
Official title:
National Registry of IgG4-RD in China
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.
Status | Recruiting |
Enrollment | 900 |
Est. completion date | December 2026 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Conforming to the diagnostic criteria of IgG4-RD (2011); Exclusion Criteria: - Excluding other mimicing IgG4-RD, including tumors, vasculitis and sarcoidosis. |
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Organ involvements of Chinese IgG4-RD patients | To calculate the percentage of organ involvements in at least 900 patients. | 5 years | |
Secondary | Response rate of glucocorticoids and immunosuppressants on IgG4-RD in China | 5 years | ||
Secondary | Relapse rate of IgG4-RD patients in China | 5 years | ||
Secondary | The correlation between baseline disease activities and relapse rate. | 5 years | ||
Secondary | The incidence rate of tumor in IgG4 related disease patients in China. | 5 years | ||
Secondary | Ten year survival rate of patients with IgG4 related disease in China. | 10 years | ||
Secondary | The imaging features of involved organs. | 3 years | ||
Secondary | The sensitivity and specificity of IgG4 positive plasma cells in pathological diagnosis of IgG4 related disease. | 3 years |
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