Circulating Plasmablast in Diagnosis and Relapse Prediction of IgG4-RD

Chinese Academy of Medical Sciences & Peking Union Medical College logo

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.

Trial contacts and locations

1

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Central trial contact

Panpan Zhang, Doctor

Data sourced from clinicaltrials.gov

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