The Expression of Immune Checkpoint CD28 rs1980422-related Single-nucleotide Polymorphisms in the Primary Immune Thrombocytopenia

Not Applicable

• Conditions: Immune Thrombocytopenia
• Interventions: Genetic: Genotyping of rs1980422-related single-nucleotide polymorphisms by real time PCR

• Registration Number: NCT05468866
• Lead Sponsor: Sohag University

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-19
• Study First Submitted QC: 2022-07-19
• Last Update Submitted: 2022-07-19
• Study First Posted: 2022-07-21
• Last Update Posted: 2022-07-21
• Study Start: 2022-09-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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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) .

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group (I)	Genotyping of rs1980422-related single-nucleotide polymorphisms by real time PCR	Group (I): represents the healthy control individuals (30 person) (recruited from the blood donors at the blood bank)
Group (II)	Genotyping of rs1980422-related single-nucleotide polymorphisms by real time PCR	Group (II): represents the cases of immune thrombocytopenia (70 cases).

Primary Outcome Measures

Name	Time	Method
rs1980422-related single-nucleotide polymorphisms	6 months	Genotyping of rs1980422-related single-nucleotide polymorphisms by real time PCR.

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt