National Registry of IRPF in China
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|ClinicalTrials.gov Identifier: NCT04314323|
Recruitment Status : Recruiting
First Posted : March 19, 2020
Last Update Posted : March 19, 2020
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.
|Condition or disease|
|Idiopathic Retroperitoneal Fibrosis|
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.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||National Registry of Idiopathic Retroperitoneal Fibrosis in China|
|Estimated Study Start Date :||March 17, 2020|
|Estimated Primary Completion Date :||March 2030|
|Estimated Study Completion Date :||March 2030|
- Organ involvements of Chinese IRPF patients [ Time Frame: 5 years ]To calculate the percentage of organ involvements in at least 500 patients.
- Response rate of treatment with glucocorticoids and immunosuppressants on IRPF in China [ Time Frame: 5 years ]
- Relapse rate of IRPF patients in China [ Time Frame: 5 years ]
- The correlation between baseline disease activities and relapse rate. [ Time Frame: 5 years ]
- Ten year survival rate of patients with IRPF in China. [ Time Frame: 10 years ]
- The imaging features of involved organs. [ Time Frame: 3 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04314323
|Contact: Yunyun Feiemail@example.com|
|Contact: Wen Zhangfirstname.lastname@example.org|