Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032, China
Location status: Recruiting
NCT Number: NCT03023371
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.
Interested in participating?
Request InfoAll sexes
Observational
Beijing, Beijing Municipality, 100032, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 5 years
To calculate the percentage of organ involvements in at least 900 patients.
Time frame: 5 years
Time frame: 5 years
Time frame: 5 years
Time frame: 5 years
Time frame: 10 years
Time frame: 3 years
Time frame: 3 years
Contact information is provided by the study sponsor or research team.
Peking Union Medical College Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06285539
Autoimmune Diseases, Behcet Syndrome
Amsterdam, Netherlands
View Trial DetailsNCT06663618
Autoimmune Diseases, IgG4-related Disease
Beijing, Beijing Municipality, China
View Trial DetailsNCT06497387
Autoimmune Diseases, Connective Tissue Diseases
Wuhan, Hubei, China
View Trial DetailsNCT06497361
Autoimmune Diseases, Connective Tissue Diseases
Wuhan, Hubei, China
View Trial Details