National Registry of IgG4-RD in China
1 other identifier
observational
900
1 country
1
Brief Summary
The aim of this study is to establish a nation-wide cohort study of IgG4-related disease (IgG4-RD) in China. Methods: All the patients fulfilling diagnostic criteria of IgG4-RD (2011) 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 IgG4-RD 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 Dec 2016
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
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 2, 2017
CompletedFirst Posted
Study publicly available on registry
January 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 24, 2017
January 1, 2017
10 years
January 2, 2017
January 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Organ involvements of Chinese IgG4-RD patients
To calculate the percentage of organ involvements in at least 900 patients.
5 years
Secondary Outcomes (7)
Response rate of glucocorticoids and immunosuppressants on IgG4-RD in China
5 years
Relapse rate of IgG4-RD patients in China
5 years
The correlation between baseline disease activities and relapse rate.
5 years
The incidence rate of tumor in IgG4 related disease patients in China.
5 years
Ten year survival rate of patients with IgG4 related disease in China.
10 years
- +2 more secondary outcomes
Eligibility Criteria
IgG4-RD patients around China
You may qualify if:
- Conforming to the diagnostic criteria of IgG4-RD (2011);
You may not qualify if:
- Excluding other mimicing IgG4-RD, including tumors, vasculitis and sarcoidosis.
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 IgG4-RD 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
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 2, 2017
First Posted
January 18, 2017
Study Start
December 1, 2016
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 24, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will share