Plasmablast Detection From IgG4-Related Disease Patients

NCT03466970 | Unknown

• 1 other identifier: 0217-17
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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

Conditions

IgG4-related Disease

Outcome Measures

Primary Outcomes (1)

• plasmablast measurement in peripheral blood of IgG4-RD patients

  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.

  1 year

Study Arms (2)

IgG4 patient

20 samples of IgG4 patients

healthy donors

20 healthy donors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients that obtaining their written consent.
• 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.
• Patients at their primary diagnosis or follow up will be eligible for this study.

You may not qualify if:

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

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (2)

Yael Eizikovits

Kfar Saba, 44281, Israel

Location

Meir health center

Kfar Saba, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

20 samples of IgG4 patients and 20 healthy donors

MeSH Terms

Conditions

Immunoglobulin G4-Related Disease

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Study Officials

• Yair Levy, prof

  head of internal medicin E

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yael Eizikovits, Mrs

CONTACT

972-09-7471936; yael.eizikovits@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of internal medicin E

Study Record Dates

• First Submitted: February 25, 2018
• First Posted: March 15, 2018
• Study Start: April 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: April 1, 2019
• Last Updated: March 16, 2018

Record last verified: 2018-03

Locations

IL (2)