| NCT ID | NCT04314323 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Idiopathic Retroperitoneal Fibrosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2020-03-17 |
| Primary Completion | 2030-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2020-03-17 with a primary completion date of 2030-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04314323 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Idiopathic Retroperitoneal Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04314323 currently recruiting?
Yes, NCT04314323 is actively recruiting participants. Contact the research team at feiyunyun2013@hotmail.com for enrollment information.
Where is the NCT04314323 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT04314323 clinical trial?
NCT04314323 is sponsored by Peking Union Medical College Hospital. The trial plans to enroll 500 participants.