Evaluation of Serum Galectin-9 Level in Systemic Lupus Erythematosus Patients and it's Association With Disease Activity and Organ Damage
Primary Purpose
Systemic Lupus Erythematosus
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Serum galectin-9 level
Sponsored by
About this trial
This is an interventional diagnostic trial for Systemic Lupus Erythematosus
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Systemic lupus erythematosus patients
Control group
Arm Description
Evaluation of serum galectin-9 level
Evaluation of serum galectin-9 level
Outcomes
Primary Outcome Measures
Evaluate serum galectin-9 level in SLE patients and compare it with the serum galectin-9 level in healthy controls.
Compare level of galectin-9 in SLE patients with that of healthy controls
Secondary Outcome Measures
compare galectin-9 in SLE patients with active and inactive renal disease.
Comparison of marker level between patients with active renal disease and patients without a tive renal disease
Full Information
NCT ID
NCT04558814
First Posted
September 16, 2020
Last Updated
September 23, 2020
Sponsor
Assiut University
1. Study Identification
Unique Protocol Identification Number
NCT04558814
Brief Title
Evaluation of Serum Galectin-9 Level in Systemic Lupus Erythematosus Patients and it's Association With Disease Activity and Organ Damage
Official Title
Evaluation of Serum Galectin-9 Level in Systemic Lupus Erythematosus Patients and it's Association With Disease Activity and Organ Damage
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Systemic lupus erythematosus patients
Arm Type
Other
Arm Description
Evaluation of serum galectin-9 level
Arm Title
Control group
Arm Type
Other
Arm Description
Evaluation of serum galectin-9 level
Intervention Type
Diagnostic Test
Intervention Name(s)
Serum galectin-9 level
Intervention Description
Determining level of galectin-9 in sera of patients of SLE with different disease activity and organ affection and Sera of control group
Primary Outcome Measure Information:
Title
Evaluate serum galectin-9 level in SLE patients and compare it with the serum galectin-9 level in healthy controls.
Description
Compare level of galectin-9 in SLE patients with that of healthy controls
Time Frame
One year
Secondary Outcome Measure Information:
Title
compare galectin-9 in SLE patients with active and inactive renal disease.
Description
Comparison of marker level between patients with active renal disease and patients without a tive renal disease
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reem Hossam Abd El-rahman, Master
Phone
01033992163
Email
medohossamkikii@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Essam Ahmed Mohamed abda, Professor
Phone
01003889450
Email
essamabda@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona Hussein, Doctor
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31405929
Citation
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Results Reference
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31044165
Citation
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Results Reference
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31653670
Citation
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Results Reference
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PubMed Identifier
31497305
Citation
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Results Reference
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PubMed Identifier
31130331
Citation
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Results Reference
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PubMed Identifier
31660791
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
31600237
Citation
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Citation
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Results Reference
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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
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