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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

Primary Purpose

Systemic Lupus Erythematosus

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Serum galectin-9 level
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Systemic Lupus Erythematosus

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesAccepts 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

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

    First Posted
    September 16, 2020
    Last Updated
    September 23, 2020
    Sponsor
    Assiut University
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    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
    Muslimov IA, Iacoangeli A, Eom T, Ruiz A, Lee M, Stephenson S, Ginzler EM, Tiedge H. Neuronal BC RNA Transport Impairments Caused by Systemic Lupus Erythematosus Autoantibodies. J Neurosci. 2019 Sep 25;39(39):7759-7777. doi: 10.1523/JNEUROSCI.1657-18.2019. Epub 2019 Aug 12.
    Results Reference
    result
    PubMed Identifier
    31044165
    Citation
    Catalina MD, Bachali P, Geraci NS, Grammer AC, Lipsky PE. Gene expression analysis delineates the potential roles of multiple interferons in systemic lupus erythematosus. Commun Biol. 2019 Apr 23;2:140. doi: 10.1038/s42003-019-0382-x. eCollection 2019.
    Results Reference
    result
    PubMed Identifier
    31653670
    Citation
    Kudose S, Santoriello D, Bomback AS, Stokes MB, D'Agati VD, Markowitz GS. Sensitivity and Specificity of Pathologic Findings to Diagnose Lupus Nephritis. Clin J Am Soc Nephrol. 2019 Nov 7;14(11):1605-1615. doi: 10.2215/CJN.01570219. Epub 2019 Oct 25.
    Results Reference
    result
    PubMed Identifier
    31497305
    Citation
    Ronnblom L, Leonard D. Interferon pathway in SLE: one key to unlocking the mystery of the disease. Lupus Sci Med. 2019 Aug 13;6(1):e000270. doi: 10.1136/lupus-2018-000270. eCollection 2019.
    Results Reference
    result
    PubMed Identifier
    31130331
    Citation
    Matta B, Barnes BJ. Coordination between innate immune cells, type I IFNs and IRF5 drives SLE pathogenesis. Cytokine. 2020 Aug;132:154731. doi: 10.1016/j.cyto.2019.05.018. Epub 2019 May 23.
    Results Reference
    result
    PubMed Identifier
    31660791
    Citation
    Brohawn PZ, Streicher K, Higgs BW, Morehouse C, Liu H, Illei G, Ranade K. Type I interferon gene signature test-low and -high patients with systemic lupus erythematosus have distinct gene expression signatures. Lupus. 2019 Nov;28(13):1524-1533. doi: 10.1177/0961203319885447. Epub 2019 Oct 29.
    Results Reference
    result
    PubMed Identifier
    31986153
    Citation
    Matsuoka N, Fujita Y, Temmoku J, Furuya MY, Asano T, Sato S, Matsumoto H, Kobayashi H, Watanabe H, Suzuki E, Kozuru H, Yastuhashi H, Migita K. Galectin-9 as a biomarker for disease activity in systemic lupus erythematosus. PLoS One. 2020 Jan 27;15(1):e0227069. doi: 10.1371/journal.pone.0227069. eCollection 2020.
    Results Reference
    result
    PubMed Identifier
    31969388
    Citation
    Chen HY, Wu YF, Chou FC, Wu YH, Yeh LT, Lin KI, Liu FT, Sytwu HK. Intracellular Galectin-9 Enhances Proximal TCR Signaling and Potentiates Autoimmune Diseases. J Immunol. 2020 Mar 1;204(5):1158-1172. doi: 10.4049/jimmunol.1901114. Epub 2020 Jan 22.
    Results Reference
    result
    PubMed Identifier
    31600237
    Citation
    Vilar KM, Pereira MC, Tavares Dantas A, de Melo Rego MJB, Pitta IDR, Pinto Duarte ALB, da Rocha Pitta MG. Galectin-9 gene (LGALS9) polymorphisms are associated with rheumatoid arthritis in Brazilian patients. PLoS One. 2019 Oct 10;14(10):e0223191. doi: 10.1371/journal.pone.0223191. eCollection 2019.
    Results Reference
    result
    PubMed Identifier
    22553077
    Citation
    Petri M, Orbai AM, Alarcon GS, Gordon C, Merrill JT, Fortin PR, Bruce IN, Isenberg D, Wallace DJ, Nived O, Sturfelt G, Ramsey-Goldman R, Bae SC, Hanly JG, Sanchez-Guerrero J, Clarke A, Aranow C, Manzi S, Urowitz M, Gladman D, Kalunian K, Costner M, Werth VP, Zoma A, Bernatsky S, Ruiz-Irastorza G, Khamashta MA, Jacobsen S, Buyon JP, Maddison P, Dooley MA, van Vollenhoven RF, Ginzler E, Stoll T, Peschken C, Jorizzo JL, Callen JP, Lim SS, Fessler BJ, Inanc M, Kamen DL, Rahman A, Steinsson K, Franks AG Jr, Sigler L, Hameed S, Fang H, Pham N, Brey R, Weisman MH, McGwin G Jr, Magder LS. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012 Aug;64(8):2677-86. doi: 10.1002/art.34473.
    Results Reference
    result

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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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