National Registry of IRPF in China

Last updated: March 17, 2020
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Scar Tissue

Treatment

N/A

Clinical Study ID

NCT04314323
IRPF group in China
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Conforming to the diagnostic criteria of IRPF;Definite IRPF must have the followingcharacteristics: (1) The typical finding of Imaging shows retroperitoneal mass,surrounding the abdominal aorta and iliac arteries, with encasement of ureters and/ororgan dysfunction; (2) Exclusion of disease progression after standard glucocorticoidtreatment; and (3) histopathological findings shows a fibrous tissue with signs ofchronic inflammation. The inflammatory component is comprised of lymphocytes, plasmacells and macrophages. Neutrophils and granulomas are rare findings. Possible IRPFrequired (1) and (2), but without histopathological examination.

Exclusion

Exclusion Criteria:

  • None of them met the criteria for other autoimmune diseases. None had malignantdisease. Secondary forms of RPF related to drugs, infections, malignancies,Erdheim-Chester disease and IgG4-RD, need to be excluded.

Study Design

Total Participants: 500
Study Start date:
March 17, 2020
Estimated Completion Date:
March 31, 2030

Study 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.

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, Beijing 100032
    China

    Active - Recruiting

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