ThrombocytopeniaFoxP3ITPNCT05410249
Assessment of FOXP3 Gene Polymorphisms and Serum Interleukin 10 in Patients With ITP
An observational study of Thrombocytopenia, run by Sohag University at 1 site in Egypt.
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]. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thrombocytopenia
- What is being tested?
- Serum IL10 By ELISA, SNP -3279 A/C of FOXP3 and SNP-924 A/G Of FOXP3
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2022to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Patients with primary ITP and aged 18 and older will be included in the study.
Who cannot join
- 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] .
- Patients with accompanying autoimmune disorders such as systemic lupus erythematosus (SLE).
- Patients with malignancies will be excluded
Trial locations and contacts
1 site in 1 country.
Mahmoud G Mahmoud, lecturer contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty Of Medicine
Sohag, 82524
Noha S Shafik, lecturer, 00201067261504, Nohasaber@med.sohag.edu.eg
Mahmoud G Mahmoud, Lecturer, mahmoudgaber@med.sohag.edu.eg
About this study
Official title: Assessment of FOXP3 Gene Polymorphisms and Serum Interleukin 10 and Their Clinical Significance in Adult Patients With Immune Thrombocytopenia
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].
Read the 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
- Thrombocytopenia
- Being tested
- Serum IL10 By ELISA, SNP -3279 A/C of FOXP3, SNP-924 A/G Of FOXP3
- Keywords
- polymorphism, FOXp3, serum IL10
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum IL10 By ELISADiagnostic test
measurement Of IL10 by ELISA
SNP -3279 A/C of FOXP3Diagnostic test
Genotyping of -6054 del/ATT will be performed using the real-time polymerase chain reaction.
SNP-924 A/G Of FOXP3Diagnostic test
Genotyping of -924 A/G polymorphisms was performed using the real-time polymerase chain reaction.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Serum IL10 By ELISA; Diagnostic Test: SNP -3279 A/C of FOXP3; Diagnostic Test: SNP-924 A/G Of FOXP3 | |
| normal individuals | The control group will be age-matched and sex-matched normal healthy volunteers. Receives: Diagnostic Test: Serum IL10 By ELISA; Diagnostic Test: SNP -3279 A/C of FOXP3; Diagnostic Test: SNP-924 A/G Of FOXP3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SNP effect in FOXP3 gene in patients ITP
different genotypes of FOXP3 in patients with ITP will be determined using real time PCR
Measured: 26 May to August 2022
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
Measured: 26 May to August 2022
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
Measured: 26 May to August 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start10 Jun 2022
- Primary completion26 Dec 2022
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Saber Shafik, Sohag University
- Investigators
- Asmaa A Abdelbaset, lecturer, Principal investigator, faculty of medicine, Sohag university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410249
- Sponsor's protocol ID
- Soh-Med-22-4-34
- Acronym
- FoxP3ITP
- Status last verified
- Apr 2023
- First submitted
- 27 May 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24433387
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of FOXP3 Gene Polymorphisms and Serum Interleukin 10 and Their Clinical Significance in Adult Patients With Immune Thrombocytopenia
- ClinicalTrials.gov ID
- NCT05410249
- Acronym / sponsor ID
- FoxP3ITP / Soh-Med-22-4-34
- Conditions
- Thrombocytopenia
- Keywords
- polymorphism, FOXp3, serum IL10
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 26 Dec 2022 (actual)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with primary ITP | – | Diagnostic Test: Serum IL10 By ELISA, Diagnostic Test: SNP -3279 A/C of FOXP3, Diagnostic Test: SNP-924 A/G Of FOXP3Patients 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 | – | Diagnostic Test: Serum IL10 By ELISA, Diagnostic Test: SNP -3279 A/C of FOXP3, Diagnostic Test: SNP-924 A/G Of FOXP3The control group will be age-matched and sex-matched normal healthy volunteers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients with primary ITP and aged 18 and older will be included in the study.
Key exclusion criteria (3 listed)
- 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] .
- Patients with accompanying autoimmune disorders such as systemic lupus erythematosus (SLE).
- Patients with malignancies will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum IL10 By ELISAmeasurement Of IL10 by ELISA | Diagnostic test | Patients with primary ITP, normal individuals |
| SNP -3279 A/C of FOXP3Genotyping of -6054 del/ATT will be performed using the real-time polymerase chain reaction. | Diagnostic test | Patients with primary ITP, normal individuals |
| SNP-924 A/G Of FOXP3Genotyping of -924 A/G polymorphisms was performed using the real-time polymerase chain reaction. | Diagnostic test | Patients with primary ITP, normal individuals |
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Background: PubMed 24433387Ballantine 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud G Mahmoud, lecturer contact
Asmaa A Abdelbaset, lecturer principal investigator
faculty of medicine, Sohag university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopenia, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noha S Shafik, lecturer (01067261504, Nohasaber@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SNP effect in FOXP3 gene in patients ITP (time frame: 26 May to August 2022). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05410249, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.