Actively Recruiting
A Prospective Cohort Study of Idiopathic Retroperitoneal Fibrosis in China
Led by Peking Union Medical College Hospital · Updated on 2020-03-18
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the disease progression and treatment responses of patients with idiopathic retroperitoneal fibrosis (IRPF), a rare condition that causes inflammation and fibrosis around major abdominal arteries and can lead to kidney problems. This study focuses on Chinese patients diagnosed with IRPF to better understand their clinical features, demographics, laboratory and imaging results, and treatment outcomes. It is a prospective cohort study enrolling patients from across China. Patients with definite or possible IRPF will be included. Definite IRPF is identified by imaging showing retroperitoneal masses around the abdominal aorta and iliac arteries with ureteral involvement, no disease progression after glucocorticoid treatment, and specific histopathological signs of inflammation. Possible IRPF includes the imaging and treatment response criteria without biopsy confirmation. Patients with secondary forms of RPF or other autoimmune diseases are excluded. Data will be collected via an online platform, including symptoms, lab tests, imaging, pathology, treatment, and side effects. Participants will provide informed consent and contribute data over several years. Researchers will monitor organ involvement as the primary outcome over five years and assess treatment response, disease relapse, correlation between disease activity and relapse, survival rates, and imaging features during follow-up. Statistical analysis will summarize clinical and laboratory characteristics to improve understanding of IRPF and its management in the Chinese population.
CONDITIONS
Brief Title
A Prospective Cohort Study of IRPF in China
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 to 75 years
- Patients diagnosed with definite or possible idiopathic retroperitoneal fibrosis (IRPF)
- Able and willing to provide informed consent
You will not qualify if you...
- Secondary forms of IRPF
- Pregnant females or those planning to become pregnant soon
- Severe, uncontrolled, or unstable diseases
- Patients with malignancy (cancer) or other autoimmune diseases excluding IRPF conditions related to drugs, infections, malignancies, Erdheim-Chester disease, or IgG4-related disease (IgG4-RD) involvement of retroperitoneum or abdominal aorta and iliac arteries
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 years
Participants diagnosed with idiopathic retroperitoneal fibrosis are observed with regular collection of demographic data, symptoms, physical examinations, laboratory findings, imaging, and pathology results throughout their disease course.
Visits scheduled over several years depending on disease status
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100032
Actively Recruiting
Research Team
Y
Yunyun Fei, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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