Lymphocyte Immunophenotyping in Common Variable Immunodeficiency
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|ClinicalTrials.gov Identifier: NCT01196702|
Recruitment Status : Unknown
Verified September 2010 by Barts & The London NHS Trust.
Recruitment status was: Recruiting
First Posted : September 8, 2010
Last Update Posted : September 8, 2010
The purpose of this study is to discover if differences in the surface markers of B-cells (antibody producing cells of the immune system) in Common Variable Immune Deficiency (CVID) are related to CVID or its complications/treatment (e.g. bronchiectasis, granulomatous disease, immunoglobulin treatment).
The study hypothesis is that the altered B-cell surface markers are related to CVID, and not to the complications or treatment of CVID.
|Condition or disease|
|Common Variable Immunodeficiency Granulomatous Disease Bronchiectasis Immunoglobulin Treatment|
|Study Type :||Observational|
|Estimated Enrollment :||210 participants|
|Observational Model:||Case Control|
|Official Title:||Investigation of the Lymphocyte Surface Expression of Patients With Primary Immunodeficiency (Common Variable Immunodeficiency (CVID)), Compared to Controls|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||June 2010|
|Estimated Study Completion Date :||July 2011|
Patients with common variable immunodeficiency
CVID and granulomatous disease
Patients with CVID complicated with granulomatous inflammation
CVID and bronchiectasis
Patients with CVID complicated by bronchiectasis
Control on Immunoglobulin
Patients on immunoglobulin long-term who do not have an immunodeficiency
Controls with bronchiectasis not caused by a known immunodeficiency
Control with granulomatous disease
Control patients with Crohn's Disease as this is a disease that causes granulomatous inflammation.
- Percentage of B-cells of all lymphocytes [ Time Frame: 5 months ]Look at percentage of cells within the lymphocyte gate that express the B-cell marker CD19, and compare to healthy controls and non-healthy controls.
- Percentage of class switched memory B-cells as a percentage of B-cells [ Time Frame: 5 months ]Percentage of class-switched memory B-cells (expressing CD27 and CD19), that do not express IgM or IgD, as a percentage of B-cells. This is reduced in CVID and this will be compared between controls and the patients with CVID.
- Percentage expression of CD21 and CD38 [ Time Frame: 5 months ]Look for abnormalities in the CVID group and compare to control groups in the numeber of B-cells expressing low levels of CD21 (CD21 lo), and high CD38.
Biospecimen Retention: Samples With DNA
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): NCT01196702
|Contact: Philip Bright, MBBSemail@example.com|
|Contact: Hilary Bright, MBBSfirstname.lastname@example.org|
|Barts and the London NHS Trust||Recruiting|
|London, United Kingdom, E1 1BB|
|Contact: Gerry Leonard 02078827260 email@example.com|
|Principal Investigator: Hilary Longhurst, MBBS, PhD|
|Principal Investigator:||Hilary Longhurst, MBBS, PhD||Barts and the London NHS Trust|