National registry for idiopathic retroperitoneal fibrosis in China
National Registry of Idiopathic Retroperitoneal Fibrosis in China
This study is trying to gather information from patients with idiopathic retroperitoneal fibrosis in China to better understand the condition and its effects on people's health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT04314323 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a nationwide cohort of patients diagnosed with idiopathic retroperitoneal fibrosis (IRPF) across multiple centers in China. Patients meeting the diagnostic criteria for IRPF will be enrolled, and their clinical manifestations, demographic features, laboratory characteristics, and treatment outcomes will be recorded in an online database. The study seeks to provide a comprehensive understanding of IRPF in the Chinese population, focusing on both primary and secondary endpoints related to the disease's characteristics and prognosis.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with newly diagnosed idiopathic retroperitoneal fibrosis who meet specific diagnostic criteria.
Not a fit: Patients with secondary forms of retroperitoneal fibrosis or those with malignancies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding and management of idiopathic retroperitoneal fibrosis, leading to improved patient outcomes.
How similar studies have performed: While this study is a novel approach in establishing a national registry for IRPF, similar cohort studies have shown success in other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Conforming to the diagnostic criteria of IRPF;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: * None of them met the criteria for other autoimmune diseases. None had malignant disease. Secondary forms of RPF related to drugs, infections, malignancies, Erdheim-Chester disease and IgG4-RD, need to be excluded.
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yunyun Fei
- Email: feiyunyun2013@hotmail.com
- Phone: +8613681125226
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.