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A Prospective Cohort Study of IRPF in China (IRPF)

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ClinicalTrials.gov Identifier: NCT04312854
Recruitment Status : Recruiting
First Posted : March 18, 2020
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Wen Zhang, Peking Union Medical College Hospital

Brief Summary:

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.


Condition or disease
Idiopathic Retroperitoneal Fibrosis

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
Official Title: A Prospective Cohort Study of Idiopathic Retroperitoneal Fibrosis in China
Actual Study Start Date : January 17, 2020
Estimated Primary Completion Date : January 2030
Estimated Study Completion Date : January 2030

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Organ involvements of Chinese IRPF patients [ Time Frame: 5 years ]
    To calculate the percentage of organ involvements in at least 500 patients.


Secondary Outcome Measures :
  1. Response rate of glucocorticoids and immunosuppressants on IRPF in China [ Time Frame: 5 years ]
  2. Relapse rate of IRPF patients in China [ Time Frame: 5 years ]
  3. The correlation between baseline disease activities and relapse rate. [ Time Frame: 5 years ]
  4. Ten-year survival rate of patients with IRPF in China. [ Time Frame: 10 years ]
  5. The imaging features of involved organs. [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
Blood samples(serum and plasma,with DNA)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with newly diagnosed IRPF
Criteria

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.


Information from the National Library of Medicine

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): NCT04312854


Contacts
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Contact: Yunyun Fei, MD 86-10-69158797 feiyunyun2013@hotmail.com

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100032
Contact: Yunyun Fei    +8613681125226    feiyunyun2013@hotmail.com   
Contact: Wen Zhang       zhangwen91@sina.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Wen Zhang, MD Department of Rheumatology,Peking Union Medical College Hospital
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Responsible Party: Wen Zhang, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04312854    
Other Study ID Numbers: IRPF-Cohort in China
First Posted: March 18, 2020    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wen Zhang, Peking Union Medical College Hospital:
idiopathic retroperitoneal fibrosis
Registry
cohort study
Additional relevant MeSH terms:
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Fibrosis
Retroperitoneal Fibrosis
Pathologic Processes