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临床试验/NCT05428111
NCT05428111Unknown不适用

Expression of Programmed Death-1 (PD-1) & Programmed Death Ligand-1 (PDL-1) in Acute Lymphoblastic Leukemia in Pediatric

Sohag University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Programmed death ligand -1 (PDL-1) by flow cytometry immunophynotyping

研究概览

简要总结

Acute lymphoblastic leukemia (ALL) is the most common childhood malignancy in the world.

It is a malignant clonal proliferation of lymphoid progenitor cells, but most commonly of the B cell lineage (B ALL). .

Acute Lymphoblastic Leukemia (ALL) is a heterogeneous disease that causes malignant hematological disorders at any age. It mainly affects children aged 2 to 5; in fact, 60% of pediatric leukemia cases are ALL, with an incidence of 3-4 cases per 100,000 per year. It is divided into two subtypes B-ALL and T-ALL depending on whether transformation occurs in B- or T-cell precursors, respectively .

Leukemic cells apply multiple immune evasion mechanisms resulting in tumor progression. One of the most important immune escape mechanisms is over expression of immune checkpoint receptors and their ligands such as PD-1 and PD-L1 .

The PD-1 receptor plays a crucial role in a broad spectrum of immune regulatory mechanisms .

It is a negative co-receptor that down regulates T-cell activity .

PDL 1, which is known as B7 H1 , is a cell surface protein of B7 family member .

PD L1 is expressed on all types of lympho hematopoietic cells at variable levels and is constitutively expressed on T cells, B cells, macrophages, and dendritic cells .

Tumors exploit the PD-1/PD-L1 pathway to evade host immune surveillance .

PD-1/PD-L1 pathway controls the induction and maintenance of immune tolerance within the tumor microenvironment. The activity of PD-1 and its ligands PD-L1 or PD-L2 are responsible for T cell activation, proliferation, and cytotoxic secretion in cancer to produce anti-tumor immune responses .

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 Day 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age range from 1 day to 18 years old
  • Patients who are newly diagnosed and under treatment of acute lymphoblastic leukemia

排除标准

  • Other types of acute leukemia rather than acute lymphoblastic leukemia

结局指标

主要结局

Programmed death ligand -1 (PDL-1) by flow cytometry immunophynotyping

时间窗: 6 months

Assess programmed death ligand -1 by flow cytometry immunophynotyping

programmed death-1 (PD-1) by flow cytometry immunophynotyping

时间窗: 6 months

Assess programmed death-1 by flow cytometry immunophynotyping

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

Nada Mohamed Rafat

resident doctor at clinical pathology department at sohag oncology center

Sohag University

研究点 (1)

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