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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04558814
Recruitment Status : Not yet recruiting
First Posted : September 22, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
RHAbdelrahman, Assiut University

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

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Diagnostic Test: Serum galectin-9 level Not Applicable

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.

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Study Type : Interventional
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Serum Galectin-9 Level in Systemic Lupus Erythematosus Patients and it's Association With Disease Activity and Organ Damage
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Systemic lupus erythematosus patients
Evaluation of serum galectin-9 level
Diagnostic Test: Serum 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

Control group
Evaluation of serum galectin-9 level
Diagnostic Test: Serum 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




Primary Outcome Measures :
  1. Evaluate serum galectin-9 level in SLE patients and compare it with the serum galectin-9 level in healthy controls. [ Time Frame: One year ]
    Compare level of galectin-9 in SLE patients with that of healthy controls


Secondary Outcome Measures :
  1. compare galectin-9 in SLE patients with active and inactive renal disease. [ Time Frame: One year ]
    Comparison of marker level between patients with active renal disease and patients without a tive renal disease



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04558814


Contacts
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Contact: Reem Hossam Abd El-rahman, Master 01033992163 medohossamkikii@gmail.com
Contact: Essam Ahmed Mohamed abda, Professor 01003889450 essamabda@hotmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Mona Hussein, Doctor
Publications of Results:

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Responsible Party: RHAbdelrahman, Resident doctor, Assiut University
ClinicalTrials.gov Identifier: NCT04558814    
Other Study ID Numbers: Galectin-9 in SLE
First Posted: September 22, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases