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

Thrombocytopenia Clinical Trial

— FoxP3ITP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05410249
• Other study ID #: Soh-Med-22-4-34
• Status: Recruiting
• Start date: June 10, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: April 2023
• Source: Sohag University
• Contact: Noha S Shafik, lecturer
• Phone: 01067261504
• Email: Nohasaber[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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].

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: September 30, 2023
• Est. primary completion date: December 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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

Related Conditions & MeSH terms

• Thrombocytopenia

Intervention

Diagnostic Test:
• Serum IL10 By ELISA
measurement Of IL10 by ELISA
• SNP -3279 A/C of FOXP3
Genotyping of -6054 del/ATT will be performed using the real-time polymerase chain reaction.
• SNP-924 A/G Of FOXP3
Genotyping of -924 A/G polymorphisms was performed using the real-time polymerase chain reaction.

Locations

Country	Name	City	State
Egypt	Faculty Of Medicine	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Ballantine LE, Ong J, Midgley A, Watson L, Flanagan BF, Beresford MW. The pro-inflammatory potential of T cells in juvenile-onset systemic lupus erythematosus. Pediatr Rheumatol Online J. 2014 Jan 16;12:4. doi: 10.1186/1546-0096-12-4. — View Citation

Outcome

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