Clinical Trials Directory

Trials / Unknown

UnknownNCT05410249

Assessment of FOXP3 Gene Polymorphisms and Serum Interleukin 10 in Patients With ITP

Assessment of FOXP3 Gene Polymorphisms and Serum Interleukin 10 and Their Clinical Significance in Adult Patients With Immune Thrombocytopenia

Status
Unknown
Phase
Study type
Observational
Enrollment
130 (estimated)
Sponsor
Sohag University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

Immune thrombocytopenia (ITP) is an autoimmune condition characterized by increased platelet destruction and suppression of production resulting in isolated thrombocytopenia. The exact etiology of ITP is unknown; however, multiple disease mechanisms exist and are mostly related to immune dysregulation \[1\]. Many studies in recent years have indicated that regulatory T cells (Tregs) play a critical role in the maintenance of immunological tolerance, and they have been reported to be defective in ITP patients, either numerically or functionally. \[2-6\]. They inhibit the activation and proliferation of effector T cells by the secretion of cytokines such as interleukin-10 (IL-10) and tumor growth factor-β (TGF-β) and by cell-to-cell interaction \[7, 8\].

Detailed description

The suppressor function of Treg cells may be compromised if the FOXP3 gene is deficient. FOXP3 gene single nucleotide polymorphisms (SNPs), particularly regulatory polymorphisms in the promoter regions, have been linked to a variety of autoimmune diseases, including allergic rhinitis, type I diabetes (TID), systemic lupus erythematosus (SLE), multiple sclerosis (MS), and autoimmune thyroid diseases (AITD), according to numerous studies \[9-13\]. The FOXP3 gene's promoter region, which is crucial in gene expression and Treg activation, may contain important SNPs. The 6054 del/ATT and 924A \> G SNPs are functionally well-defined and are distinguished by the relevance of studies on them among these SNPs. \[14, 15\]. The Interleukin 10 (IL-10) cytokine is required for regulating immune functions by promoting the widespread suppression of immune responses through its pleiotropic effects. IL-10 secretion from CD4+CD25+FoxP3+ regulatory cells (Tregs), macrophages and other leukocytes followed by subsequent binding to IL-10 receptors on macrophages and dendritic cells (DCs) has been linked to reduced antigen presentation and increased T-cell anergy \[16\]. The relationship between the two FOXP3 polymorphisms and ITP has not been well elucidated, hence the objective of this study is to explore if these functional polymorphisms are linked to ITP, how they correlate to IL-10 levels, and how they relate to other features of clinical presentation in adult patients with ITP.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTSerum IL10 By ELISAmeasurement Of IL10 by ELISA
DIAGNOSTIC_TESTSNP -3279 A/C of FOXP3Genotyping of -6054 del/ATT will be performed using the real-time polymerase chain reaction.
DIAGNOSTIC_TESTSNP-924 A/G Of FOXP3Genotyping of -924 A/G polymorphisms was performed using the real-time polymerase chain reaction.

Timeline

Start date
2022-06-10
Primary completion
2022-12-26
Completion
2023-09-30
First posted
2022-06-08
Last updated
2023-04-12

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05410249. Inclusion in this directory is not an endorsement.