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

Recruiting

• Conditions: Thrombocytopenia
• Interventions: Diagnostic Test: Serum IL10 By ELISA; Diagnostic Test: SNP -3279 A/C of FOXP3; Diagnostic Test: SNP-924 A/G Of FOXP3

• Registration Number: NCT05410249
• Lead Sponsor: Sohag University

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-06-06
• Study First Posted: 2022-06-08
• Study Start: 2022-06-10
• Primary Completion: 2022-12-26
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Patients with primary ITP and aged 18 and older will be included in the study.

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Exclusion Criteria

1. Patients under 18 and those with proven secondary ITP [as cases initiated by or associated with infections due to human immunodeficiency virus (HIV-associated), hepatitis B virus, or hepatitis C virus-associated secondary ITP] .
2. Patients with accompanying autoimmune disorders such as systemic lupus erythematosus (SLE).
3. Patients with malignancies will be excluded

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with primary ITP	SNP-924 A/G Of FOXP3	Patients with primary ITP and aged 18 and older will be included in the study. Patients under 18 and those with proven secondary ITP \[as cases initiated by or associated with infections due to human immunodeficiency virus (HIV-associated), hepatitis B virus, or hepatitis C virus-associated secondary ITP\] will be excluded. Moreover, patients with accompanying autoimmune disorders such as systemic lupus erythematosus (SLE) and patients of malignancies were excluded.
normal individuals	SNP -3279 A/C of FOXP3	The control group will be age-matched and sex-matched normal healthy volunteers.
Patients with primary ITP	Serum IL10 By ELISA	Patients with primary ITP and aged 18 and older will be included in the study. Patients under 18 and those with proven secondary ITP \[as cases initiated by or associated with infections due to human immunodeficiency virus (HIV-associated), hepatitis B virus, or hepatitis C virus-associated secondary ITP\] will be excluded. Moreover, patients with accompanying autoimmune disorders such as systemic lupus erythematosus (SLE) and patients of malignancies were excluded.
Patients with primary ITP	SNP -3279 A/C of FOXP3	Patients with primary ITP and aged 18 and older will be included in the study. Patients under 18 and those with proven secondary ITP \[as cases initiated by or associated with infections due to human immunodeficiency virus (HIV-associated), hepatitis B virus, or hepatitis C virus-associated secondary ITP\] will be excluded. Moreover, patients with accompanying autoimmune disorders such as systemic lupus erythematosus (SLE) and patients of malignancies were excluded.
normal individuals	Serum IL10 By ELISA	The control group will be age-matched and sex-matched normal healthy volunteers.
normal individuals	SNP-924 A/G Of FOXP3	The control group will be age-matched and sex-matched normal healthy volunteers.

Primary Outcome Measures

Name	Time	Method
Association of serum IL-10 levels in both groups( patients with ITP and normal control)	26 May to August 2022	measurement of serum IL10 in patients with ITP and normal controls using ELISA
Association of SNP in FOXP3 gene and the clinical presentation in adult patients with ITP	26 May to August 2022	evaluation and statistical analysis of effect of SNP in FOXP3 in the clinical picture in adult patients with ITP
SNP effect in FOXP3 gene in patients ITP	26 May to August 2022	different genotypes of FOXP3 in patients with ITP will be determined using real time PCR

Trial Locations

Locations (1)

Faculty Of Medicine; 🇪🇬 Sohag, Egypt