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Circulating Plasmablast in Diagnosis and Relapse Prediction of IgG4-RD

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ClinicalTrials.gov Identifier: NCT04539197
Recruitment Status : Recruiting
First Posted : September 4, 2020
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Study Description
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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.

Condition or disease
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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 660 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: Detection of Circulating Plasmablast in Diagnosis and Relapse Prediction of IgG4 Related Diseases
Actual Study Start Date : June 10, 2020
Estimated Primary Completion Date : June 10, 2022
Estimated Study Completion Date : September 10, 2022

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Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. plasmablast/plasma cells in the diagnosis of IgG4-RD [ Time Frame: 24 months ]
    plasmablast/plasma cells will be detected in IgG4-RD, other autoimmune disease and IgG4-RD mimickers at baseline.

  2. plasmablast/plasma cells in relapse prediction of IgG4-RD [ Time Frame: 24 months ]
    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.


Biospecimen Retention:   Samples Without DNA
3-5 ml peripheral blood was collected for PBMC seperation.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04539197


Contacts
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Contact: Panpan Zhang, Doctor 18800159311 panpanzhang2016@163.com

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100005
Contact: Panpan Zhang    18800159311    panpanzhang2016@163.com   
Principal Investigator: Wen Zhang, MD,phD         
Sponsors and Collaborators
Peking Union Medical College Hospital
More Information
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Publications of Results:

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04539197    
Other Study ID Numbers: Plasmablast in IgG4-RD
First Posted: September 4, 2020    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking Union Medical College Hospital:
IgG4 related disease
plasmablast/plasma cells
diagnosis
relapse
Additional relevant MeSH terms:
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Immunoglobulin G4-Related Disease
Recurrence
Disease Attributes
 Pathologic Processes
Autoimmune Diseases
Immune System Diseases