We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessment of FOXP3 Gene Polymorphisms and Serum Interleukin 10 in Patients With ITP (FoxP3ITP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05410249
Recruitment Status : Recruiting
First Posted : June 8, 2022
Last Update Posted : April 12, 2023
Sponsor:
Information provided by (Responsible Party):
Noha Saber Shafik, Sohag University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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].


Condition or disease Intervention/treatment
Thrombocytopenia Diagnostic Test: Serum IL10 By ELISA Diagnostic Test: SNP -3279 A/C of FOXP3 Diagnostic Test: SNP-924 A/G Of FOXP3

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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Assessment of FOXP3 Gene Polymorphisms and Serum Interleukin 10 and Their Clinical Significance in Adult Patients With Immune Thrombocytopenia
Actual Study Start Date : June 10, 2022
Actual Primary Completion Date : December 26, 2022
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Patients with primary ITP
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.
 Diagnostic Test: Serum IL10 By ELISA
measurement Of IL10 by ELISA

Diagnostic Test: SNP -3279 A/C of FOXP3
Genotyping of -6054 del/ATT will be performed using the real-time polymerase chain reaction.

Diagnostic Test: SNP-924 A/G Of FOXP3
Genotyping of -924 A/G polymorphisms was performed using the real-time polymerase chain reaction.
normal individuals
The control group will be age-matched and sex-matched normal healthy volunteers.
 Diagnostic Test: Serum IL10 By ELISA
measurement Of IL10 by ELISA

Diagnostic Test: SNP -3279 A/C of FOXP3
Genotyping of -6054 del/ATT will be performed using the real-time polymerase chain reaction.

Diagnostic Test: SNP-924 A/G Of FOXP3
Genotyping of -924 A/G polymorphisms was performed using the real-time polymerase chain reaction.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. SNP effect in FOXP3 gene in patients ITP [ Time Frame: 26 May to August 2022 ]
    different genotypes of FOXP3 in patients with ITP will be determined using real time PCR

  2. Association of serum IL-10 levels in both groups( patients with ITP and normal control) [ Time Frame: 26 May to August 2022 ]
    measurement of serum IL10 in patients with ITP and normal controls using ELISA

  3. Association of SNP in FOXP3 gene and the clinical presentation in adult patients with ITP [ Time Frame: 26 May to August 2022 ]
    evaluation and statistical analysis of effect of SNP in FOXP3 in the clinical picture in adult patients with ITP


Biospecimen Retention:   Samples With DNA

!0 ml blood will be aspirated from the both groups and will be subjected to the following investigations:

  1. Complete blood count.
  2. Renal and liver function tests.
  3. Serology for HCV, HBV, and HIV.
  4. Antinuclear antibody
  5. Bone marrow examination.
  6. Serum IL-10 by enzyme-linked immunosorbent assay (ELISA).
  7. Genotyping of -6054 del/ATT and -924 A/G polymorphisms was performed using the real-time polymerase chain reaction.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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.

All patients will be subjected to a thorough assessment of history, complete clinical examination, and investigations

Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05410249


Contacts
Layout table for location contacts
Contact: Noha S Shafik, lecturer 01067261504 Nohasaber@med.sohag.edu.eg
Contact: Mahmoud G Mahmoud, lecturer Mahmoudgaber@med.sohag.edu.eg

Locations
Layout table for location information
Egypt
Faculty Of Medicine Recruiting
Sohag, Egypt, 82524
Contact: Noha S Shafik, lecturer    00201067261504    Nohasaber@med.sohag.edu.eg   
Contact: Mahmoud G Mahmoud, Lecturer       mahmoudgaber@med.sohag.edu.eg   
Principal Investigator: Asmaa Baset, Lecturer         
Principal Investigator: Moustafa A Younis, Lecturer         
Principal Investigator: Alshimaa H Abdelall, Lecturer         
Principal Investigator: Mahmoud Ibrahim, lecturer         
Sponsors and Collaborators
Sohag University
Investigators
Layout table for investigator information
Principal Investigator: Asmaa A Abdelbaset, lecturer faculty of medicine, Sohag university
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Noha Saber Shafik, lecturer of medical microbiology and immunology, faculty of medicine, Sohag University
ClinicalTrials.gov Identifier: NCT05410249    
Other Study ID Numbers: Soh-Med-22-4-34
First Posted: June 8, 2022    Key Record Dates
Last Update Posted: April 12, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Noha Saber Shafik, Sohag University:
polymorphism
FOXp3
serum IL10
Additional relevant MeSH terms:
Layout table for MeSH terms
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases