Idiopathic Retroperitoneal Fibrosis Clinical Trial
Official title:
National Registry of Idiopathic Retroperitoneal Fibrosis in China
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.
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.
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