National Registry of IgG4-RD in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Organ involvements of Chinese IgG4-RD patients
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Conforming to the diagnostic criteria of IgG4-RD (2011);
排除标准
- •Excluding other mimicing IgG4-RD, including tumors, vasculitis and sarcoidosis.
结局指标
主要结局
Organ involvements of Chinese IgG4-RD patients
时间窗: 5 years
To calculate the percentage of organ involvements in at least 900 patients.
次要结局
- Relapse rate of IgG4-RD patients in China(5 years)
- Ten year survival rate of patients with IgG4 related disease in China.(10 years)
- Response rate of glucocorticoids and immunosuppressants on IgG4-RD in China(5 years)
- The imaging features of involved organs.(3 years)
- The sensitivity and specificity of IgG4 positive plasma cells in pathological diagnosis of IgG4 related disease.(3 years)
- The correlation between baseline disease activities and relapse rate.(5 years)
- The incidence rate of tumor in IgG4 related disease patients in China.(5 years)
研究者
Wen Zhang
Professor
Peking Union Medical College Hospital