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NCF Gene & TNFSF4 in SLE Patients

Primary Purpose

System; Lupus Erythematosus

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TNFS4, NCF gene
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for System; Lupus Erythematosus focused on measuring TNFS4, NCF gene

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • SLE patients
  • patients older than 18 years old

Exclusion Criteria:

  • patients with other connective tissue diseases
  • patients older than 70 years old

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SLE patients

    Arm Description

    Outcomes

    Primary Outcome Measures

    Concentration of gene polymorphism of the TNFS4 & NCF in SLE Egyptian patients.
    Identify the number of Participants with SNP polymorphisms in the TNFS4, and NCF gene in SLE Egyptian patients and the relation between the concentration of polymorphism and disease activity

    Secondary Outcome Measures

    Full Information

    First Posted
    March 26, 2022
    Last Updated
    April 4, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05314881
    Brief Title
    NCF Gene & TNFSF4 in SLE Patients
    Official Title
    Polymorphisms of the Tumor Necrosis Factor Superfamily 4 and Neutrophil Cytosolic Factor Gene in SLE Egyptian Patients.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2022 (Anticipated)
    Primary Completion Date
    June 2022 (Anticipated)
    Study Completion Date
    July 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
    the investigators objective is to identify the association of SNP polymorphisms in the TNFS4, and NCF gene and SLE Egyptian patients.
    Detailed Description
    Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by clinical heterogeneity with variable severity. Among the SLE patients, two may share the same clinical manifestations but have different phenotypes. This is why studies are searching for the different genes that might be associated with SLE susceptibility. The Neutrophil cytosolic factor (NCF) Gene provide the instruction for the synthesis of group of proteins that form the NADPH oxidase enzyme complex, that is critical for the induction of reactive oxygen species (ROS) which in turn is important in the regulation of immune system. While the Tumor necrosis factor superfamily 4 (TNFSF4) encodes the ligand for OX40 (OX40L), which delivers a strong costimulatory signal to activated effector T-cells and enhances both Th1 and Th2 responses when engaged with its receptor. Therefore, increased levels of cell surface OX40L may augment B cell differentiation and proliferation. The consequence of which is that the resulting autoantibodies and immune complexes cause disease pathology in SLE. So, NCF and TNFSF4 gene polymorphism are supposed to be associated with SLE risk and pathophysiology.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    System; Lupus Erythematosus
    Keywords
    TNFS4, NCF gene

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    65 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SLE patients
    Arm Type
    Experimental
    Intervention Type
    Genetic
    Intervention Name(s)
    TNFS4, NCF gene
    Intervention Description
    study the gene polymorphisms from the blood sample of the included SLE patients
    Primary Outcome Measure Information:
    Title
    Concentration of gene polymorphism of the TNFS4 & NCF in SLE Egyptian patients.
    Description
    Identify the number of Participants with SNP polymorphisms in the TNFS4, and NCF gene in SLE Egyptian patients and the relation between the concentration of polymorphism and disease activity
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: SLE patients patients older than 18 years old Exclusion Criteria: patients with other connective tissue diseases patients older than 70 years old
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yasmine Makarem, Dr
    Phone
    +201002929015
    Email
    yasmine.saad@aun.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marwa Galal, Dr
    Phone
    +201006783422
    Email
    marwa.a.galal@aun.edu.eg

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29308728
    Citation
    Aziz MM, Galal MAA, Elzohri MH, El-Nouby F, Leong KP. Cross-cultural adaptation and validation of Systemic Lupus Erythematosus Quality of Life questionnaire into Arabic. Lupus. 2018 Apr;27(5):780-787. doi: 10.1177/0961203317747714. Epub 2018 Jan 7.
    Results Reference
    background
    PubMed Identifier
    20035223
    Citation
    Kaiser R, Criswell LA. Genetics research in systemic lupus erythematosus for clinicians: methodology, progress, and controversies. Curr Opin Rheumatol. 2010 Mar;22(2):119-25. doi: 10.1097/BOR.0b013e3283361943.
    Results Reference
    background
    PubMed Identifier
    26683156
    Citation
    Holmdahl R, Sareila O, Olsson LM, Backdahl L, Wing K. Ncf1 polymorphism reveals oxidative regulation of autoimmune chronic inflammation. Immunol Rev. 2016 Jan;269(1):228-47. doi: 10.1111/imr.12378.
    Results Reference
    background
    PubMed Identifier
    22850862
    Citation
    Lu MM, Xu WD, Yang J, Ye QL, Feng CC, Li J, Pan HF, Tao JH, Wang J, Ye DQ. Association of TNFSF4 polymorphisms with systemic lupus erythematosus: a meta-analysis. Mod Rheumatol. 2013 Jul;23(4):686-93. doi: 10.1007/s10165-012-0708-8. Epub 2012 Aug 1.
    Results Reference
    background
    PubMed Identifier
    10637265
    Citation
    Lane P. Role of OX40 signals in coordinating CD4 T cell selection, migration, and cytokine differentiation in T helper (Th)1 and Th2 cells. J Exp Med. 2000 Jan 17;191(2):201-6. doi: 10.1084/jem.191.2.201. No abstract available.
    Results Reference
    background
    PubMed Identifier
    16924108
    Citation
    Ito T, Wang YH, Duramad O, Hanabuchi S, Perng OA, Gilliet M, Qin FX, Liu YJ. OX40 ligand shuts down IL-10-producing regulatory T cells. Proc Natl Acad Sci U S A. 2006 Aug 29;103(35):13138-43. doi: 10.1073/pnas.0603107103. Epub 2006 Aug 21.
    Results Reference
    background
    PubMed Identifier
    19319144
    Citation
    Croft M. The role of TNF superfamily members in T-cell function and diseases. Nat Rev Immunol. 2009 Apr;9(4):271-85. doi: 10.1038/nri2526.
    Results Reference
    background
    PubMed Identifier
    7749983
    Citation
    Stuber E, Neurath M, Calderhead D, Fell HP, Strober W. Cross-linking of OX40 ligand, a member of the TNF/NGF cytokine family, induces proliferation and differentiation in murine splenic B cells. Immunity. 1995 May;2(5):507-21. doi: 10.1016/1074-7613(95)90031-4.
    Results Reference
    background
    PubMed Identifier
    28606963
    Citation
    Olsson LM, Johansson AC, Gullstrand B, Jonsen A, Saevarsdottir S, Ronnblom L, Leonard D, Wettero J, Sjowall C, Svenungsson E, Gunnarsson I, Bengtsson AA, Holmdahl R. A single nucleotide polymorphism in the NCF1 gene leading to reduced oxidative burst is associated with systemic lupus erythematosus. Ann Rheum Dis. 2017 Sep;76(9):1607-1613. doi: 10.1136/annrheumdis-2017-211287. Epub 2017 Jun 12.
    Results Reference
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