Evaluation of Serum Galectin-9 Level in Systemic Lupus Erythematosus Patients and it's Association With Disease Activity and Organ Damage

Assiut University

Status: Unknown

Conditions: Systemic Lupus Erythematosus

Treatments: Diagnostic Test: Serum galectin-9 level

Study type: Interventional

Funder types: Other

Identifiers

NCT04558814

Galectin-9 in SLE

Details and patient eligibility

About

Study aims to evaluate serum galectin-9 in systemic lupus erythematosus patients and determine it's correlation with overall disease process

Full description

Systemic lupus erythematosus (SLE) is an autoimmune disease characterized by producing large quantities of antibodies directed against self-antigens, particularly double stranded DNA (dsDNA) and small nuclear RNA-binding proteins such as Ro, La, Sm, and nRNP.

SLE-associated autoantibodies and high serum interferon alpha (IFN-α) are two important heritable phenotypes in SLE which are thought to play a role in disease pathogenesis . The most remarkable feature of the anti DNA response is its association with immunopathologic events especially glomerulonephritis . Immune complexes containing DNA can promote the expression of interferon alpha (IFN-alpha) by a specialized population of dendritic cells known as plasmacytoid dendritic cells .

Activation of the type I interferon (IFN) system is associated with disease pathogenesis in SLE, with affected patients typically demonstrating high concentrations of type I IFN proteins . Overexpression of type I IFN-induced genes that includes hundreds of gene transcripts; which is termed interferon signature (IFNGS), has been observed in 60-80% of adults and the majority of children with SLE .

Galectin-9 (Gal-9) is recognized as a novel, easy to measure biomarker for type1 IFN signatures and galectin-9 could aid in clinical decision making in SLE as a marker for disease activity and organ damage.

Galectin-9 is expressed by T cells, macro-phages, fibroblasts, and endothelial cells, its secreted form is barely detected under physiological conditions, it plays an recognizable role in the regulation of inflammation and immune responses by down-regulating pro-inflammatory T cells.

Enrollment: 100 estimated patients

Sex: All

Ages: 16 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• clinically diagnosed systemic lupus erythematosus patients.

Exclusion criteria

• Individuals with other autoimmune diseases: 1)rheumatoid arthritis patients 2)dermatomyositis 3)scleroderma 4)mixed connective tissue disease

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Systemic lupus erythematosus patients

Other group

Description:

Evaluation of serum galectin-9 level

Treatment:

Diagnostic Test: Serum galectin-9 level

Control group

Other group

Description:

Evaluation of serum galectin-9 level

Treatment:

Diagnostic Test: Serum galectin-9 level