Clinical trial NCT04539197: Circulating Plasmablast in Diagnosis and Relapse Prediction of IgG4-RD
Official title: Detection of Circulating Plasmablast in Diagnosis and Relapse Prediction of IgG4 Related Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Plasmablast/Plasma Cells in Diagnosis of IgG4-RD
Plasmablast/Plasma Cells in Relapse Prediction of IgG4-RD
Keywords: IgG4 related disease
plasmablast/plasma cells
diagnosis
relapse
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 300 IgG4-RD patients, 200 other autoimmune diseases, 60 IgG4-RD mimickers (pancreatic cancer, cholangiocarcinoma, vasculitis, lymphoproliferative diseases, inflammatory bowel disease, kimura disease) and 100 healthy controls were enrolled.

Brief summary: 300 IgG4-RD patients, 200 other autoimmune diseases, 60 IgG4-RD mimickers and 100 healthy controls were enrolled. Circulating plasmablast/plasma cells were detected of all patients at baseline and healthy controls. IgG4-RD patients were followed up every 3-6 months. Circulating plasmablast/plasma cells were also detected at disease remission and relapse. IgG4-RD patients' clinical data and laboratory parameters were collected.

Detailed description: 300 IgG4-RD patients, 200 other autoimmune diseases, 60 IgG4-RD mimickers (pancreatic cancer, cholangiocarcinoma, vasculitis, lymphoproliferative diseases, inflammatory bowel disease, kimura disease) and 100 healthy controls were enrolled. Peripheral blood samples of 5-10 ml were collected from all patients and healthy controls. Serum was separated for ELISA detection. Circulating plasmablast/plasma cells were detected of all patients at baseline and healthy controls. IgG4-RD patients were followed up every 3-6 months. Circulating plasmablast/plasma cells were also detected at disease remission and relapse. IgG4-RD patients' clinical data and laboratory parameters were collected. Data were analyzed to evaluate plasmablast/plasma cells in diagnosis and relapse prediction of IgG4-RD.

Eligibility criteria: Inclusion Criteria:

* IgG4-RD patients fulfilled the 2011 comprehensive diagnostic criteria of IgG4-RD (2011). Other autoimmune disease and IgG4-RD mimickers fulfilled the corresponding diagnostic criteria.

Exclusion Criteria:

* Patients in pregnancy or preparing to pregnancy, patients with active infection, including HIV, HCV, HBV, TB, et al.

Primary outcomes:
measure: plasmablast/plasma cells in the diagnosis of IgG4-RD
timeFrame: 24 months
measure: plasmablast/plasma cells in relapse prediction of IgG4-RD
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
citation: Lin W, Zhang P, Chen H, Chen Y, Yang H, Zheng W, Zhang X, Zhang F, Zhang W, Lipsky PE. Circulating plasmablasts/plasma cells: a potential biomarker for IgG4-related disease. Arthritis Res Ther. 2017 Feb 10;19(1):25. doi: 10.1186/s13075-017-1231-2.