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Not yet recruiting NCT07675837

Inducible Co-stimulator Gene With Systemic Lupus Erythematosus

Observational Systemic Lupus Erthematosus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Systemic Lupus Erthematosus. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Association of ICOS Gene Polymorphism With Susceptibility and Severity of Systemic Lupus Erythematosus.

Overview

The aim of this study is to investigate the association between ICOS gene polymorphism and susceptibility to systemic lupus erythematosus (SLE), as well as its impact on disease severity.

Detailed description

Systemic lupus erythematosus (SLE) is a chronic, multiorgan, systemic autoimmune disease that affects almost all tissue and organ systems, has a varied clinical appearance, and fluctuates in severity among people and over time. The global incidence of SLE has been estimated at 5.14 per 100,000 person-years with mortality rates ranging from 6.7 to 37.8 %, with women five times more likely to be affected than men. The pathogenesis of SLE is complex and involves cells of both innate and adaptive immunity. The distinguishing feature of SLE is the production of autoantibodies, with the formation of immune complexes , and result in the inflammatory response of the immune system.Costimulatory signals, which include ligands and receptors and their interactions involving multiple types of signal information, are essential for the initiation, maintenance, and regulation of immune reactions. When costimulatory factors malfunction, complex abnormal immune responses with biological effects and ultimately clinical autoimmune diseases result. Inducible co-stimulator (ICOS) is the third member of the CD28/cytotoxic T-lymphocyte associated antigen-4 family and is involved in the proliferation and activation of T cells. The inducible T cell co-stimulator (ICOS) is expressed on T cells following peptide:MHC engagement with CD28 co-stimulation. The interaction of ICOS with its sole ligand the Inducible T-cell co-stimulatory ligand (ICOSL; also known as B7-related protein-1 or ICOSL) triggers key activities of T cells including cytokine production and differentiation into the T follicular helper (Tfh) cell lineage over effector lineages. Inducible T-cell co-stimulator (ICOS)-deficient people are unable to produce T follicular helper (Tfh) cells, which are CD4 T cells that migrate into B cell follicles and promote germinal centre (GC) reactions, according to research on human patients and mice models.

In this study, we aim to explore the possible association between potentially functional SNP rs11889031 of the ICOS gene and SLE in the Egyptian population.

Primary outcome measures

  • ICOS gene polymorphism and SLE [Time frame: 6 month]
Secondary outcome measures (1)
  • systemic lupus erythematosus (SLE) Assessment [Time frame: 6 month]

Eligibility criteria

Inclusion criteria

  • Patients diagnosed with SLE based on 2019 EULAR/ACR Male or female. willing to provide written informed consent for participation and genetic testing

Exclusion criteria

  • Other autoimmune diseases or chronic inflammatory disorders. Malignancy. Pregnancy or breastfeeding. Inability to provide informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Egypt · 1 center
  • South Valley University Hospital — Qina

Identifiers

NCT: NCT07675837 · DVA021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗