National Registry of IRPF in China
National Registry of Idiopathic Retroperitoneal Fibrosis in China
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2020
CompletedStudy Start
First participant enrolled
March 17, 2020
CompletedFirst Posted
Study publicly available on registry
March 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2030
March 19, 2020
March 1, 2020
10 years
March 17, 2020
March 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Organ involvements of Chinese IRPF patients
To calculate the percentage of organ involvements in at least 500 patients.
5 years
Secondary Outcomes (5)
Response rate of treatment with glucocorticoids and immunosuppressants on IRPF in China
5 years
Relapse rate of IRPF patients in China
5 years
The correlation between baseline disease activities and relapse rate.
5 years
Ten year survival rate of patients with IRPF in China.
10 years
The imaging features of involved organs.
3 years
Eligibility Criteria
IRPF patients around China.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032, China
Biospecimen
Peripheral blood samples from IRPF patients will be saved for DNA extration and study.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 17, 2020
First Posted
March 19, 2020
Study Start
March 17, 2020
Primary Completion (Estimated)
March 1, 2030
Study Completion (Estimated)
March 1, 2030
Last Updated
March 19, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will share