Circulating Plasmablast in Diagnosis and Relapse Prediction of IgG4-RD

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Plasmablast/Plasma Cells in Diagnosis of IgG4-RD; Plasmablast/Plasma Cells in Relapse Prediction of IgG4-RD

Study type: Observational

Funder types: Other

Identifiers

NCT04539197

Plasmablast in IgG4-RD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 660 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

660 participants in 4 patient groups

IgG4-RD group

Description:

300 IgG4-RD were enrolled and followed up for more than 6 months. Peripheral blood of all patients were collected at baseline, disease remission and relpase for plasmablast/plasma cells detection. All clinical data and laboratory parameters at baseline, each follow up were collected.

other autoimmune disease group

Description:

200 patients( RA, SLE, pSS, BD, et al) were enrolled in this study. Peripheral blood of all patients were collected at baseline for plasmablast/plasma cells detection. All clinical data and laboratory parameters at baseline were collected.

IgG4-RD mimicker group

Description:

60 IgG4-RD mimickers (pancreatic cancer, cholangiocarcinoma, vasculitis, lymphoproliferative diseases, inflammatory bowel disease, kimura disease) were collected. Peripheral blood of all patients were collected at baseline for plasmablast/plasma cells detection. All clinical data and laboratory parameters at baseline were collected.

healthy control group

Description:

100 healthy controls were collected. Peripheral blood of healthy controls were collected at baseline for plasmablast/plasma cells detection. Demographic features of healthy controls were collected.