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Inducible Co-stimulator Gene With Systemic Lupus Erythematosus

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07675837
Acronym
ICOS/SLE
Enrollment
30
Registered
2026-06-30
Start date
2026-06-01
Completion date
2027-07-01
Last updated
2026-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erthematosus

Brief summary

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.

Interventions

None listed

Sponsors

South Valley University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
ICOS gene polymorphism and SLE6 monthassociation between ICOS gene polymorphism and SLE susceptibility

Secondary

MeasureTime frameDescription
systemic lupus erythematosus (SLE) Assessment6 monththe impact of the ICOS gene polymorphism on disease severity and activity using the Systemic Lupus Erythematosus Disease Activity Index Index (SLEDAI).

Countries

Egypt

Contacts

CONTACTDina Fetouh Abdel-latif, MSc
dedemoona@gmail.com+201283364643
CONTACTSoheir abdel- Hamid Ali, lecturer
Soher.abdel-hamid@med.svu.edu.eg+201066877343
STUDY_CHAIREisa Mohammed Hegazy, Professor

Dermatology, Venereology & Andrology Department ,Faculty of Medicine ,South Valley University.

STUDY_DIRECTORMohammed Hosny Hassan, Professor

Biochemistry , Qena faculty of medicine ,south valley university.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 1, 2026