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Status unknownNCT04539197Updated Sep 4, 2020

Circulating Plasmablast in Diagnosis and Relapse Prediction of IgG4-RD

An observational study in Plasmablast/Plasma Cells in Diagnosis of IgG4-RD and Plasmablast/Plasma Cells in Relapse Prediction of IgG4-RD, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-04.

Sponsored by Peking Union Medical College Hospital · Observational

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
660
Ages
18 Years to 75 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Immunoglobulin G4-Related Disease

67 studies on the registry are indexed under Immunoglobulin G4-Related Disease; 36 are open to participants now.

This study's planned enrollment of 660 is above the median of 162 across 18 observational studies indexed under Immunoglobulin G4-Related Disease.

Browse Immunoglobulin G4-Related Disease studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
660 participants (estimated)
Target follow-up
24 Months
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 months

  2. 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.

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
  • Peking Union Medical College Hospital
    Beijing, Beijing 100005, China
    Recruiting
08

References and documents

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. PubMed 28183334 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04539197
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Sponsor
First posted
Sep 4, 2020
Start date
Jun 10, 2020
Primary completion
Jun 10, 2022 (estimated)
Completion
Sep 10, 2022 (estimated)
Last update
Sep 4, 2020

Study contacts

Panpan Zhang, Doctor
Contact
panpanzhang2016@163.com
18800159311

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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