NCT04314323

National Registry of IRPF in China

National Registry of Idiopathic Retroperitoneal Fibrosis in China

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to establish a nation-wide cohort study of idiopathic retroperitoneal fibrosis (IRPF) in China. Methods: All the patients fulfilling diagnostic criteria of IRPF 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 IRPF 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 IRPF patients. Newly diagnosed IRPF patients will be recruited from all over the China. Inclusion criteria: patients with newly diagnosed IRPF will be recruited. Exclusion criteria: patients with secondary forms of retroperitoneal fibrosis or malignancy 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 sign 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 IRPF patients. The secondary endpoints include the demographic features,laboratory characteristics, immunological tests, imaging and pathological features, in addition, the treatment and prognosis of the disease.

Conditions

• Idiopathic Retroperitoneal Fibrosis

Timeline

• Start date: 2020-03-17
• Primary completion: 2030-03-01
• Completion: 2030-03-01
• First posted: 2020-03-19
• Last updated: 2020-03-19

Locations

1 site across 1 country: China