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临床试验/NCT05468866
NCT05468866Unknown不适用

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

Sohag University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
rs1980422-related single-nucleotide polymorphisms

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
1 Year 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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) .

结局指标

主要结局

rs1980422-related single-nucleotide polymorphisms

时间窗: 6 months

Genotyping of rs1980422-related single-nucleotide polymorphisms by real time PCR.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bedor Elsayed Hussien

Assistant lecturer of clinical and chemical pathology

Sohag University

研究点 (1)

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