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Circulating Plasmablast in Diagnosis and Relapse Prediction of IgG4-RD

Detection of Circulating Plasmablast in Diagnosis and Relapse Prediction of IgG4 Related Diseases

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04539197
Enrollment
660
Registered
2020-09-04
Start date
2020-06-10
Completion date
2022-09-10
Last updated
2020-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

None listed

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
plasmablast/plasma cells in the diagnosis of IgG4-RD24 monthsplasmablast/plasma cells will be detected in IgG4-RD, other autoimmune disease and IgG4-RD mimickers at baseline.
plasmablast/plasma cells in relapse prediction of IgG4-RD24 monthsIgG4-RD patients will be followed up for at least 6 months. plasmablast/plasma cells will be detected at baseline, disease remission and disease relapse.

Countries

China

Contacts

Primary ContactPanpan Zhang, Doctor
panpanzhang2016@163.com18800159311

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026