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

NCT07136337 | Not Yet Recruiting DMC

• 1 other identifier: TigG and TigM in SLE
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• to measure the level of these novel biomarkers and evaluate their role as diagnostic biomarkers in SLE .

  2 years

Secondary Outcomes (1)

• Study the correlation of TIgG and TIgM with different SLE manifestations and with disease activity and damage index

  2 years

Study Arms (2)

Systemic lupus erythematosus patients

EXPERIMENTAL

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

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

Helthy control

OTHER

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

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

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

Helthy control; Systemic lupus erythematosus patients

Eligibility Criteria

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

You may qualify if:

• : Adult SLE Patients ( \>18 years ) who are fulfilling the 2019 ACR\\EULAR classification criteria of systemic lupus erythematosus

You may not qualify if:

• SLE patients \<18 years old
• Patients with other autoimmune diseases (systemic sclerosis , sjogren syndrome, rheumatoid arthritis dermatomyositis, mixed connective tissue disease).
• Pregnant and lactating women .

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, Asyut Governorate, 1111, Egypt

Location

Related Links

• Related Info

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mai Hany Ahmed Ibrahim

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: August 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

EG (1)