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
About this trial
This is an interventional basic science trial for System; Lupus Erythematosus focused on measuring TNFS4, NCF gene
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
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
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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NCF Gene & TNFSF4 in SLE Patients
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