The Diagnostic Utility of T Immunoglobulin G and T Immunoglobulin M Biomarkers in Patients With Systemic Lupus Erythematosus Disease : Associations With Disease Activity and Damage

Sponsor
Assiut University
Study ID
NCT07136337
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 4 ml. of fresh venous blood will be collected from each patient on EDTA tube and will be used for detection of the following : T cell immunoglobulin G ( TIgG) and T cell immunoglobulin M (TIgM) by — DIAGNOSTIC_TEST
    4 ml. of fresh venous blood will be collected from each patient on EDTA tube and will be used for detection of the following : T cell immunoglobulin G ( TIgG) and T cell immunoglobulin M (TIgM) by flow cytometry

Study Details

The SLE is heterogeneous multisystem autoimmune disease with complex pathogenesis involves multiple cellular components of the innate and adaptive immune systems, presence of autoantibodies and immune complexes, engagement of the complement system, dysregulation of several cytokines including type I interferons, and disruption of the clearance of nucleic acids after cell death(1,2,3). Among the putative mechanisms leading to the pathogenic breakdown of immune tolerance in SLE is the development of auto reactive T Cells, which contribute to pathologic activation of B cells, dysfunction of regulatory T Cells and aberrant production of pro-inflammatory cytokines (4,5) Autoantibodies targeting the T Cell Receptor (TCR)/CD3 have been demonstrated to activate Ca2+/calmodulin-dependent kinase IV (CaMKIV), resulting in diminished IL-2 production and low serum IL-2 levels are commonly observed in SLE (6,7,8,9) T Cell autoantibodies have been shown to influence T Cell signalling, migration, and adhesion, contributing to organ-specific targeting in SLE. These findings suggest that T Cell autoantibodies are active participants in disease pathogenesis and , supporting their potential as biomarkers for diagnosis and disease activity (10) Delays in SLE diagnosis, often due to the limitations of current biomarkers, can lead to worsened outcomes (11). Improved diagnostic markers, such as the T Cell biomarkers described here, could help reduce these delays , improve patient care and improve the ability of clinicians to differentiate between SLE and patients with falsely positive ANA (12) To the best of our knowledge, only a limited number of studies have explored the role of T cell autoantibodies in diagnosing and monitoring disease activity in SLE (12), and none have examined their association with lupus nephritis and disease damage index .

Key Dates

First listed
Aug 22, 2025
Start date
Sep 30, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Systemic lupus erythematosus patients
    4 ml. of fresh venous blood will be collected from each patient on EDTA tube and will be used for detection of the following : T cell immunoglobulin G ( TIgG) and T cell immunoglobulin M (TIgM) by flow cytometry
  • Other: Helthy control
    4 ml. of fresh venous blood will be collected from each patient on EDTA tube and will be used for detection of the following : T cell immunoglobulin G ( TIgG) and T cell immunoglobulin M (TIgM) by flow cytometry

Primary Outcome Measure

to measure the level of these novel biomarkers and evaluate their role as diagnostic biomarkers in SLE . [ Time Frame: 2 years ]

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