NCT03023371

National Registry of IgG4-RD in China

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 900 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• IgG4-Related Disease

Timeline

• Start date: 2016-12-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2017-01-18
• Last updated: 2017-01-24

Locations

1 site across 1 country: China