- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04312854
A Prospective Cohort Study of IRPF in China (IRPF)
A Prospective Cohort Study of Idiopathic Retroperitoneal Fibrosis in China
This is a cohort study to investigate the disease course and treatment response of patients with idiopathic retroperitoneal fibrosis(IRPF).
Methods: All the patients fulfilling diagnostic criteria of IRPF would be enrolled around China. A online database system will 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.
Study Overview
Status
Conditions
Detailed Description
Idiopathic retroperitoneal fibrosis(IRPF) is a rare fibro-inflammatory disease that develops around the abdominal aorta and the iliac arteries, and spreads into the adjacent retroperitoneum, where it frequently causes ureteral obstruction and renal failure. The clinical phenotype of RPF is complex, because it can be associated with fibro-inflammatory disorders involving other organs, and often arises in patients with other autoimmune conditions.
This prospective cohort aims to study presentations of IRPF with laboratory findings and imagings throughout the disease course. Newly diagnosed IRPF patients will be recruited from all over the China.
Inclusion criteria: patients with definite, possible IRPF will be recruited.Definite IRPF must have the following characteristics: (1) The typical finding of Imaging shows retroperitoneal mass, surrounding the abdominal aorta and iliac arteries, with encasement of ureters and/or organ dysfunction; (2) Exclusion of disease progression after standard glucocorticoid treatment; and (3) histopathological findings shows a fibrous tissue with signs of chronic inflammation. The inflammatory component is comprised of lymphocytes, plasma cells and macrophages. Neutrophils and granulomas are rare findings. Possible IRPF required (1) and (2), but without histopathological examination.
Exclusion criteria: patients with malignancy or other autoimmune diseases are excluded. Secondary forms of RPF related to drugs, infections, malignancies, Erdheim-Chester disease and IgG4-RD, need to be excluded.
The data will be uploaded through the platform of Chinese Rheumatology Information Platform. Demographic data, initial symptoms, disease duration, 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 including the demographic features,laboratory characteristics, immunological tests, imaging and pathological features, in addition, the treatment and prognosis of the disease.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Yunyun Fei, MD
- Phone Number: 86-10-69158797
- Email: feiyunyun2013@hotmail.com
Study Locations
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Beijing
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Beijing, Beijing, China, 100032
- Recruiting
- Peking Union Medical College Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Males and females; 18-75 years old with informed consent; Patients diagnosed with definite or possible IRPF.
Exclusion Criteria:
Secondary forms of IRPF; Pregnant or Females planning to bear a child recently ; Concurrent severe and/or uncontrolled and/or unstable diseases; Patients with malignancy.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Organ involvements of Chinese IRPF patients
Time Frame: 5 years
|
To calculate the percentage of organ involvements in at least 500 patients.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The correlation between baseline disease activities and relapse rate.
Time Frame: 5 years
|
5 years
|
The imaging features of involved organs.
Time Frame: 3 years
|
3 years
|
Relapse rate of IRPF patients in China
Time Frame: 5 years
|
5 years
|
Response rate of glucocorticoids and immunosuppressants on IRPF in China
Time Frame: 5 years
|
5 years
|
Ten-year survival rate of patients with IRPF in China.
Time Frame: 10 years
|
10 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Wen Zhang, MD, Department of Rheumatology,Peking Union Medical College Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRPF-Cohort in China
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
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