Circulating Plasmablast in Diagnosis and Relapse Prediction of IgG4-RD

Plasmablast/Plasma Cells in Diagnosis of IgG4-RD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04539197
• Other study ID #: Plasmablast in IgG4-RD
• Status: Recruiting
• Start date: June 10, 2020
• Est. completion date: September 10, 2022

Study information

• Verified date: June 2020
• Source: Peking Union Medical College Hospital
• Contact: Panpan Zhang, Doctor
• Phone: 18800159311
• Email: panpanzhang2016[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 660
• Est. completion date: September 10, 2022
• Est. primary completion date: June 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Plasmablast/Plasma Cells in Diagnosis of IgG4-RD
• Plasmablast/Plasma Cells in Relapse Prediction of IgG4-RD
• Recurrence

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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