The Expression of Immune Checkpoint CD28 rs1980422-related Single-nucleotide Polymorphisms in the Primary Immune Thrombocytopenia
Primary Purpose
Immune Thrombocytopenia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Genotyping of rs1980422-related single-nucleotide polymorphisms by real time PCR
Sponsored by
About this trial
This is an interventional diagnostic trial for Immune Thrombocytopenia
Eligibility Criteria
Inclusion Criteria:
- approval to sign an informed written consent
- patient with newly diagnosed ITP
- platelet count of peripheral blood < 100×109/ L on at least two consecutive routine blood tests, normal or increased megakaryocyte count in bone marrow (as previously diagnosed)
- no other disease or condition related to thrombocytopenia
- patient age > 1 year and < 65 years
Exclusion Criteria:
- Refusal to sign an informed written consent
- Patients with other autoimmune or hemorrhagic diseases (e.g., SLE, severe anemia), or thrombocytopenia due to pregnancy, viruses (e.g., hepatitis C virus, human immunodeficiency virus)
- active infections
- vaccinations, or drugs (e.g., heparin) .
Sites / Locations
- Sohag University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
group (I)
Group (II)
Arm Description
Group (I): represents the healthy control individuals (30 person) (recruited from the blood donors at the blood bank)
Group (II): represents the cases of immune thrombocytopenia (70 cases).
Outcomes
Primary Outcome Measures
rs1980422-related single-nucleotide polymorphisms
Genotyping of rs1980422-related single-nucleotide polymorphisms by real time PCR.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05468866
Brief Title
The Expression of Immune Checkpoint CD28 rs1980422-related Single-nucleotide Polymorphisms in the Primary Immune Thrombocytopenia
Official Title
The Expression of Immune Checkpoint CD28 rs1980422-related Single-nucleotide Polymorphisms in the Primary Immune Thrombocytopenia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary immune thrombocytopenia (ITP), one of the most common bleeding disorders, is characterized by reduced platelet count and an increased risk of bleeding ITP is an acquired autoimmune disease, in which platelets are opsonized by auto-antibodies and destroyed by phagocytic cells ITP pathogenesis involves a hyper-activated T cell response, which is important for cell-mediated cytotoxicity and IgG production Therefore, investigating T cell abnormalities in ITP patients may reveal the mechanism of pathogenesis and development of ITP.
The costimulatory molecules of T cells consist of CD28, inducible costimulatory (ICOS), TNF superfamily member 4 (TNFSF4), and DNAM1 (CD226), and the co-inhibitory molecules contain TIM3, cytotoxic T-lymphocyte associated protein 4 (CTLA4), programmed death-1 (PD1), and lymphocyte activating 3 (LAG3) Among these, CD28 and CTLA4 represent the best-studied costimulatory pathways. CD28 and CTLA4 interact with two ligands (CD80 and CD86) on the surface of antigen-presenting cells (APCs), introducing a positive stimulatory and a negative inhibitory signal into T cells, respectively
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group (I)
Arm Type
Active Comparator
Arm Description
Group (I): represents the healthy control individuals (30 person) (recruited from the blood donors at the blood bank)
Arm Title
Group (II)
Arm Type
Active Comparator
Arm Description
Group (II): represents the cases of immune thrombocytopenia (70 cases).
Intervention Type
Genetic
Intervention Name(s)
Genotyping of rs1980422-related single-nucleotide polymorphisms by real time PCR
Other Intervention Name(s)
Immunophenotyping (CD3, CD4, CD28) by flow cytometry
Intervention Description
detection of rs1980422-related single-nucleotide polymorphisms and percentage of (CD3,CD4,CD28) by immunophenotyping
Primary Outcome Measure Information:
Title
rs1980422-related single-nucleotide polymorphisms
Description
Genotyping of rs1980422-related single-nucleotide polymorphisms by real time PCR.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
approval to sign an informed written consent
patient with newly diagnosed ITP
platelet count of peripheral blood < 100×109/ L on at least two consecutive routine blood tests, normal or increased megakaryocyte count in bone marrow (as previously diagnosed)
no other disease or condition related to thrombocytopenia
patient age > 1 year and < 65 years
Exclusion Criteria:
Refusal to sign an informed written consent
Patients with other autoimmune or hemorrhagic diseases (e.g., SLE, severe anemia), or thrombocytopenia due to pregnancy, viruses (e.g., hepatitis C virus, human immunodeficiency virus)
active infections
vaccinations, or drugs (e.g., heparin) .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bedor E Hussien, assistant lecture
Phone
01066072377
Email
bodor.badr@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed A Allam, assistant professor
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama R ELsheref, professor
Email
portal@med.sohag.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
31818938
Citation
Badami E, Cexus ONF, Quaratino S. Activation-induced cell death of self-reactive regulatory T cells drives autoimmunity. Proc Natl Acad Sci U S A. 2019 Dec 26;116(52):26788-26797. doi: 10.1073/pnas.1910281116. Epub 2019 Dec 9.
Results Reference
background
PubMed Identifier
31378317
Citation
Curdy N, Lanvin O, Laurent C, Fournie JJ, Franchini DM. Regulatory Mechanisms of Inhibitory Immune Checkpoint Receptors Expression. Trends Cell Biol. 2019 Oct;29(10):777-790. doi: 10.1016/j.tcb.2019.07.002. Epub 2019 Aug 1.
Results Reference
background
PubMed Identifier
31781109
Citation
Ferreira RC, Castro Dopico X, Oliveira JJ, Rainbow DB, Yang JH, Trzupek D, Todd SA, McNeill M, Steri M, Orru V, Fiorillo E, Crouch DJM, Pekalski ML, Cucca F, Tree TI, Vyse TJ, Wicker LS, Todd JA. Chronic Immune Activation in Systemic Lupus Erythematosus and the Autoimmune PTPN22 Trp620 Risk Allele Drive the Expansion of FOXP3+ Regulatory T Cells and PD-1 Expression. Front Immunol. 2019 Nov 8;10:2606. doi: 10.3389/fimmu.2019.02606. eCollection 2019.
Results Reference
background
PubMed Identifier
31564474
Citation
Huang C, Zhu HX, Yao Y, Bian ZH, Zheng YJ, Li L, Moutsopoulos HM, Gershwin ME, Lian ZX. Immune checkpoint molecules. Possible future therapeutic implications in autoimmune diseases. J Autoimmun. 2019 Nov;104:102333. doi: 10.1016/j.jaut.2019.102333. Epub 2019 Sep 26.
Results Reference
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The Expression of Immune Checkpoint CD28 rs1980422-related Single-nucleotide Polymorphisms in the Primary Immune Thrombocytopenia
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