Circulating Plasmablast in Diagnosis and Relapse Prediction of IgG4-RD

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

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.

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Anticipated): 660

Contacts and Locations

• Study Contact: Name: Panpan Zhang, Doctor; Phone Number: 18800159311; Email: panpanzhang2016@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100005
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Panpan Zhang; Phone Number: 18800159311; Email: panpanzhang2016@163.com
      • Principal Investigator: Wen Zhang, MD,phD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
IgG4-RD group; 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; 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; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
plasmablast/plasma cells in the diagnosis of IgG4-RD	plasmablast/plasma cells will be detected in IgG4-RD, other autoimmune disease and IgG4-RD mimickers at baseline.	24 months
plasmablast/plasma cells in relapse prediction of IgG4-RD	IgG4-RD patients will be followed up for at least 6 months. plasmablast/plasma cells will be detected at baseline, disease remission and disease relapse.	24 months

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2020
• Primary Completion (Anticipated): June 10, 2022
• Study Completion (Anticipated): September 10, 2022

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: relapse; diagnosis; IgG4 related disease; plasmablast/plasma cells
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Disease Attributes; Disease; Recurrence; Immunoglobulin G4-Related Disease
• Other Study ID Numbers: Plasmablast in IgG4-RD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No