Presence of Circulating Cluster of Differentiation 4 Positive 28 Null T Helper Lymphocytes(CD4+CD28-) in Patients With Autoimmune Hemolytic Anemia.

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05711264
Collaborator
(none)
46
26

Study Details

Study Description

Brief Summary

  1. Study the presence of circulating CD4+/CD28 null T lymphocytes in AIHA either Idiopathic or Secondary.

  2. Role of CD4+/CD28 null T lymphocytes in monitoring response to therapy in AIHA.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Autoimmune hemolytic anemia (AIHA) has always been considered the simplest and most scholastic example of antibody-mediated autoimmune disease.It has been identified as a greatly heterogeneous disease, due to several immunological mechanisms involved beyond antibodies, complement and antibody-dependent cell-mediated cytotoxicity (ADCC). AIHAs may be

    Idiopathic of unknown cause Secondary associated with several conditions :

    (lymphoproliferative, autoimmune , infectious diseases, immunodeficiencies, solid tumors, transplants, and drugs).Several subsets of T and B lymphocytes with highly specialized functions have been characterized. Some lymphocytes promote inflammation, while others have anti-inflammatory roles, and an optimal balance between these two opposing sets of lymphocytes is critical for immune homeostasis. A pro-inflammatory subset of CD4+ T helper 1 (Th1) lymphocytes known as cluster of differentiation 4 positive 28 negative T helper lymphocytes (CD4+CD28 null T cells) because they characteristically lack CD28 which is a co-stimulatory receptor critical for the activation and function of T cells.CD4+CD28 null T cells are rare in healthy individuals, but they increase in inflammatory and immune-mediated diseases. Prevalence of CD4+CD28 null T cells is high in chronic inflammatory diseases, autoimmune diseases, immunodeficiency and specific infectious diseases.It remains controversial whether CD4+CD28null T cells are antigen specific and which are the precise antigens that trigger their expansion. It has been suggested that CD4+CD28null T lymphocytes are auto-reactive and that repeated stimulation by auto-antigens drives the expansion of this cell subset.Expansion of the CD4+CD28 null T-cell subset in patients affected by autoimmune disorders has been linked to the severity of disease and an unfavourable prognosis.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    46 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Presence of Circulating CD4+CD28 Null T Helper Lymphocytes in Patients With Autoimmune Hemolytic Anemia.
    Anticipated Study Start Date :
    Jan 30, 2023
    Anticipated Primary Completion Date :
    Jan 30, 2025
    Anticipated Study Completion Date :
    Apr 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Role of CD4+CD28 null T helper lymphocytes in monitoring response to therapy in AIHA using flowcytometry in serum of AIHA patients. [Baseline]

      The potential role of CD4+CD28 null T lymphocytes in monitoring response to therapy in AIHA . the percentage of circulating CD4+CD28 null T helper lymphocytes in AIHA either Idiopathic or Secondary using flowcytometry in serum of AIHA patients.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • 1- newly diagnosed patients with AIHA 2- patients with idiopathic or secondary AIHA
    Exclusion Criteria:
    • 1-current steroid therapy 2- other concurrent chronic inflammatory conditions 3-recent blood transfusion 4- active Hepatitis C virus

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Amira Ehab Salah Eldin, Resident in clinical pathology department, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05711264
    Other Study ID Numbers:
    • CD4+CD28- Lymphocyte IN AIHA
    First Posted:
    Feb 2, 2023
    Last Update Posted:
    Feb 2, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 2, 2023