Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Plasmablast Detection From IgG4-Related Disease Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03466970
Recruitment Status : Unknown
Verified March 2018 by yair levy, Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 15, 2018
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
yair levy, Meir Medical Center

Brief Summary:
IgG4-related disease (IgG4-RD) is an immune-mediated, fibro-inflammatory disease that leads to tissue damage, organ dysfunction and, if untreated, to organ failure. The disease can affect almost any anatomic location, but the sites involved most commonly are the pancreas, salivary glands, orbital adnexa, lymph nodes, and retroperitoneum. IgG4-RD, typically diagnosed among individuals who are middle-aged, is characterized by a male predominance except with regard to organs of the head and neck (e.g., the salivary glands and orbits), where the gender distribution is approximately equal. The epidemiology of IgG4-RD remains poorly understood because of its recognition only recently as a multi-organ disease. However, IgG4-RD accounts for many conditions once regarded as disparate, single-organ disorders The purpose of our study is to evaluate the method of plasmablast measurement in peripheral blood of IgG4-RD patients, for diagnosis and follow-up on disease progression and response to treatment. This document will outline the collection, processing and testing procedures for measuring plasmablasts from IgG4-RD patients

Condition or disease
IgG4-related Disease

Detailed Description:

IgG4-related disease (IgG4-RD) is an immune-mediated, fibro-inflammatory disease that leads to tissue damage, organ dysfunction and, if untreated, to organ failure. The disease can affect almost any anatomic location, but the sites involved most commonly are the pancreas, salivary glands, orbital adnexa, lymph nodes, and retroperitoneum. IgG4-RD, typically diagnosed among individuals who are middle-aged, is characterized by a male predominance except with regard to organs of the head and neck (e.g., the salivary glands and orbits), where the gender distribution is approximately equal. The epidemiology of IgG4-RD remains poorly understood because of its recognition only recently as a multi-organ disease. However, IgG4-RD accounts for many conditions once regarded as disparate, single-organ disorders.

The current gold standard for the diagnosis of IgG4-RD is the identification of characteristic histology and immunohistochemistry features through biopsy. These pathology features are consistent across the full range of organs affected by IgG4-RD. However, histopathologic variation can occur according to the stage of the lesion; that is, longstanding disease may be predominately fibrotic and a cellular. Confirming the diagnosis of IgG4-RD in such cases can be difficult. Moreover, IgG4-RD organ pathology and IgG4-RD mimickers, such as granulomatosis with polyangiitis (formerly Wegener's), sarcoidosis, histiocytosis, and malignancies (e.g., lymphoma and adenocarcinoma of the pancreas), may share similar features including an IgG4-positive plasma cell infiltrate. Reliance upon serum IgG4 concentrations to diagnose IgG4-RD is similarly problematic because both the specificity and positive predictive value of serum IgG4 concentrations are poor.

Plasmablasts, derived from the B-cell lineage and characterized as CD19lowCD20-CD38+CD27+, comprise a stage intermediate between activated B-cells and plasma cells. Plasmablasts are generally rare in the peripheral blood of healthy individuals, but expansions are observed briefly during responses to infection or vaccination. In contrast, in the setting of autoimmunity and persistent self-antigen(s), plasmablasts can circulate for prolonged periods.

Circulating plasmablasts have been described previously in inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, and multiple myeloma. Recently, several studies identified plasmablsts in IgG4-RD both as a diagnostic tool and as an indicator of response to treatment

2. Aim

The purpose of our study is to evaluate the method of plasmablast measurement in peripheral blood of IgG4-RD patients, for diagnosis and follow-up on disease progression and response to treatment. This document will outline the collection, processing and testing procedures for measuring plasmablasts from IgG4-RD patients.

3. Plasmablast source

Plasmablasts will be isolated from peripheral blood derived from patients and normal donors who consent to participate in the study. Blood samples will be drawn by a physician or accredited nurse, transferred to the research lab in order to separate PMBCs, which will be stained for CD19lowCD20-CD38+CD27+ markers and measured by flow cytometry (FACS) located at the hematology lab

Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Plasmablast Detection From IgG4-Related Disease Patients
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
IgG4 patient
20 samples of IgG4 patients
healthy donors
20 healthy donors



Primary Outcome Measures :
  1. plasmablast measurement in peripheral blood of IgG4-RD patients [ Time Frame: 1 year ]
    Plasmablasts will be isolated from peripheral blood derived from patients and normal donors who consent to participate in the study. Blood samples will be drawn by a physician or accredited nurse, transferred to the research lab in order to separate PMBCs, which will be stained for CD19lowCD20-CD38+CD27+ markers and measured by flow cytometry (FACS) located at the hematology lab.


Biospecimen Retention:   Samples Without DNA
20 samples of IgG4 patients and 20 healthy donors


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
There will be 2 groups in the study. One group of 20 IgG4 patients and the other group is 20 healthy donors.
Criteria

Inclusion Criteria:

  1. Patients that obtaining their written consent.
  2. Patients above the age of 18 and referred to the Rheumatology clinic or Internal Medicine E Department at the Meir Medical Center for investigation or treatment of IgG4-RD will be candidates to participate in the study.
  3. Patients at their primary diagnosis or follow up will be eligible for this study.

Exclusion Criteria:

  1. Patient that not diagnosed before with IgG4.
  2. patients that does not referred to the Rheumatology clinic or Internal Medicine E Department at the Meir Medical Center.

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): NCT03466970


Contacts
Layout table for location contacts
Contact: yael Eizikovits, Mrs 972-09-7471936 yael.eizikovits@clalit.org.il

Locations
Layout table for location information
Israel
Yael Eizikovits
Kfar Saba, Israel, 44281
Meir health center
Kfar-saba, Israel
Sponsors and Collaborators
Meir Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Yair Levy, prof head of internal medicin E
Layout table for additonal information
Responsible Party: yair levy, head of internal medicin E, Meir Medical Center
ClinicalTrials.gov Identifier: NCT03466970    
Other Study ID Numbers: 0217-17
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Immunoglobulin G4-Related Disease
Autoimmune Diseases
Immune System Diseases