NCF Gene & TNFSF4 in SLE Patients

NCT ID: NCT05314881

Last Updated: 2022-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-07-31

Brief Summary

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the investigators objective is to identify the association of SNP polymorphisms in the TNFS4, and NCF gene and SLE Egyptian patients.

Detailed Description

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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.

Conditions

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System; Lupus Erythematosus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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SLE patients

Group Type EXPERIMENTAL

TNFS4, NCF gene

Intervention Type GENETIC

study the gene polymorphisms from the blood sample of the included SLE patients

Interventions

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TNFS4, NCF gene

study the gene polymorphisms from the blood sample of the included SLE patients

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* SLE patients
* patients older than 18 years old

Exclusion Criteria

* patients with other connective tissue diseases
* patients older than 70 years old
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Yasmine Saad Makarem

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Yasmine Makarem, Dr

Role: CONTACT

+201002929015

Marwa Galal, Dr

Role: CONTACT

+201006783422

References

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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.

Reference Type BACKGROUND
PMID: 29308728 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20035223 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26683156 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22850862 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10637265 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16924108 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19319144 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7749983 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28606963 (View on PubMed)

Other Identifiers

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gene polymorphism in SLE

Identifier Type: -

Identifier Source: org_study_id

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