A Prospective Cohort Study of IgG4RD in China
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|ClinicalTrials.gov Identifier: NCT01670695|
Recruitment Status : Recruiting
First Posted : August 22, 2012
Last Update Posted : April 11, 2017
|Condition or disease|
Immunoglobulin G4-related disease (IgG4-RD) is a recently defined emerging clinical entity characterized by tissue infiltration by IgG4-positive plasma cells, tissue fibrosclerosis and elevated serum IgG4 concentration.
In this study, patients with IgG4-RD will be investigated, including clinical presentation, laboratory findings and imaging study. All patients will be treated by standard care and follow-uped for at least 6 months.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Cohort Study of Patients With IgG4-Related Disease|
|Actual Study Start Date :||January 2012|
|Estimated Primary Completion Date :||January 2032|
|Estimated Study Completion Date :||January 2032|
Patients with IgG4-RD, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis (Mikulicz disease and Küttner's tumor), inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions.
- Clinical Response [ Time Frame: 6 months ]Clinical Response is measured by IgG4-RD Responder Index, including organ/site score and serum IgG4 level.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670695
|Contact: Hua Chen, MDfirstname.lastname@example.org|
|Deptment of Rheumatology, Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China, 100032|
|Contact: Wen Zhang, MD 86-10-69158795 email@example.com|
|Contact: Hua Chen, MD 86-10-69158797 firstname.lastname@example.org|
|Principal Investigator:||Wen Zhang, MD||Deptment of Rheumatology, Peking Union Medical College Hospital|
|Study Chair:||Fengchun Zhang||Deptment of Rheumatology, Peking Union Medical College Hospital|