National Registry of IgG4-RD in China
ConditionIgG4-Related Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPeking Union Medical College Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Conforming to the diagnostic criteria of IgG4-RD (2011);
Disqualifiers
Excluding other mimicing IgG4-RD, including tumors, vasculitis and sarcoidosis.
Trial population
IgG4-RD patients around China
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Organ involvements of Chinese IgG4-RD patients
To calculate the percentage of organ involvements in at least 900 patients.
Time frame
5 yearsSecondary outcomes
1
Response rate of glucocorticoids and immunosuppressants on IgG4-RD in China
Time frame
5 years2
Relapse rate of IgG4-RD patients in China
Time frame
5 years3
The correlation between baseline disease activities and relapse rate.
Time frame
5 years4
The incidence rate of tumor in IgG4 related disease patients in China.
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov