Lymphocyte Immunophenotyping in Common Variable Immunodeficiency

NCT01196702 | Completed

• 1 other identifier: 006749
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Common Variable Immunodeficiency; Granulomatous Disease; Bronchiectasis; Immunoglobulin Treatment

Keywords

common variable immunodeficiency; granulomatous disease; crohns disease; bronchiectasis; immunoglobulin replacement or treatment; B-cell immunophenotyping

Outcome Measures

Primary Outcomes (2)

• Percentage of B-cells of all lymphocytes

  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.

  5 months

• Percentage of class switched memory B-cells as a percentage of B-cells

  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.

  5 months

Secondary Outcomes (1)

• Percentage expression of CD21 and CD38

  5 months

Study Arms (7)

CVID

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

Control bronchiectasis

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.

Healthy Controls

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

Adult patients selected from medical clinics in the order of attendance with common variable immunodeficiency, bronchiectasis, on long-term immunoglobulin treament and granulomatous disease. Must be able to give consent for testing of B-cell immunophenotype. Healthy control samples taken from colleagues.

You may qualify if:

• or over
• Competent to consent
• Have diagnosis of Common Variable Immunodeficiency, granulomatous disease, on long term immunoglobulin or bronchiectasis.

You may not qualify if:

• Under 18
• Unable to consent.

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

Barts and the London NHS Trust

London, E1 1BB, United Kingdom

Location

Related Publications (1)

• Wehr C, Kivioja T, Schmitt C, Ferry B, Witte T, Eren E, Vlkova M, Hernandez M, Detkova D, Bos PR, Poerksen G, von Bernuth H, Baumann U, Goldacker S, Gutenberger S, Schlesier M, Bergeron-van der Cruyssen F, Le Garff M, Debre P, Jacobs R, Jones J, Bateman E, Litzman J, van Hagen PM, Plebani A, Schmidt RE, Thon V, Quinti I, Espanol T, Webster AD, Chapel H, Vihinen M, Oksenhendler E, Peter HH, Warnatz K. The EUROclass trial: defining subgroups in common variable immunodeficiency. Blood. 2008 Jan 1;111(1):77-85. doi: 10.1182/blood-2007-06-091744. Epub 2007 Sep 26.

  PMID: 17898316 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood serum samples kept for one year in secure laboratory.

MeSH Terms

Conditions

Common Variable Immunodeficiency; Bronchiectasis; Crohn Disease

Condition Hierarchy (Ancestors)

Immunologic Deficiency Syndromes; Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Immunologist

Study Record Dates

• First Submitted: September 6, 2010
• First Posted: September 8, 2010
• Study Start: September 1, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

GB (1)