Clinical trial NCT03023371: National Registry of IgG4-RD in China
Official title: National Registry of IgG4-RD in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: IgG4-Related Disease
Keywords: Registry; cohort study; IgG4-related disease
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 900
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: IgG4-RD patients around China

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.

Detailed description: This is a multicenter registry study of IgG4-RD patients. Newly diagnosed IgG4-RD patients will be recruited from allover the China. Inclusion criteria: patients with definite, probable, or possible IgG4-RD according to the 2011 comprehensive diagnostic criteria for IgG4-RD will be recruited. Exclusion criteria: patients with malignancy or other autoimmune diseases are excluded.

The data will be uploaded through the platform of Chinese Rheumatology Information Platform. Demographic data, initial symptoms, disease duration, history of allergy, and physical examination, organ involvements, laboratory findings, radiological and pathological results, as well as treatment, side effects will be recorded.

This study was approved by the Medical Ethics Committee of PUMCH (Beijing, China). All patients will signe informed consent.

Statistical Analysis: All parameters are described in the standard summary statistics, including mean, standard deviation, minimum, and maximum. All statistical analyses will be performed by SPSS.

Endpoints: The primary endpoint is to investigate the organ involvements 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: Inclusion Criteria:

* Conforming to the diagnostic criteria of IgG4-RD (2011);

Exclusion Criteria:

* Excluding other mimicing IgG4-RD, including tumors, vasculitis and sarcoidosis.

Primary outcomes:
measure: Organ involvements of Chinese IgG4-RD patients
timeFrame: 5 years
Secondary outcomes:
measure: Response rate of glucocorticoids and immunosuppressants on IgG4-RD in China
timeFrame: 5 years
measure: Relapse rate of IgG4-RD patients in China
timeFrame: 5 years
measure: The correlation between baseline disease activities and relapse rate.
timeFrame: 5 years
measure: The incidence rate of tumor in IgG4 related disease patients in China.
timeFrame: 5 years
measure: Ten year survival rate of patients with IgG4 related disease in China.
timeFrame: 10 years
measure: The imaging features of involved organs.
timeFrame: 3 years
measure: The sensitivity and specificity of IgG4 positive plasma cells in pathological diagnosis of IgG4 related disease.
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References: