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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04558814
Enrollment
100
Registered
2020-09-22
Start date
2021-01-31
Completion date
2022-12-31
Last updated
2020-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Brief summary

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

Detailed 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.

Interventions

DIAGNOSTIC_TESTSerum galectin-9 level

Determining level of galectin-9 in sera of patients of SLE with different disease activity and organ affection and Sera of control group

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluate serum galectin-9 level in SLE patients and compare it with the serum galectin-9 level in healthy controls.One yearCompare level of galectin-9 in SLE patients with that of healthy controls

Secondary

MeasureTime frameDescription
compare galectin-9 in SLE patients with active and inactive renal disease.One yearComparison of marker level between patients with active renal disease and patients without a tive renal disease

Contacts

Primary ContactReem Hossam Abd El-rahman, Master
medohossamkikii@gmail.com01033992163
Backup ContactEssam Ahmed Mohamed abda, Professor
essamabda@hotmail.com01003889450

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026