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临床试验/NCT03249636
NCT03249636Unknown不适用

Evaluation of New Markers for Minimal Residual Disease in Precursor B Acute Lymphoblastic Leukemia

Assiut University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年12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
Level of expression of markers in acute lymphoblastic leukemia.

研究概览

简要总结

Acute lymphoblastic leukemia , also known as acute lymphocytic leukemia, characterized by the overproduction and accumulation of cancerous, immature white blood cells, known as lymphoblasts, causing damage and death by inhibiting the production of normal cells (such as red and white blood cells and platelets) in the bone marrow and by spreading (infiltrating) to other organs. Acute lymphoblastic leukemia is most common in childhood, with a peak incidence at 2-5 years of age and another peak in old age.

详细描述

In recent years, new pieces of information obtained through immunophenotyping, cytogenetics and genomic profiling. Chemotherapy resistance have contributed to a better understanding of the pathology of this complex disorder and to recognition of subgroups of patients who respond differently to therapy.

The possible impact of the expression of various markers has been studied in ALL.

In patients with acute leukemia, treatment decisions are based on the status of peripheral blood and bone marrow cellularity. This provides a measure of the efficacy of therapy and can reveal leukemia relapse. The reliability of morphologic examination of peripheral blood and bone marrow largely depends on the hematologist's expertise, and its sensitivity is fundamentally limited by the similarities in appearance between leukemic cells and normal lympho-hematopoietic progenitors. Therefore, patients in complete morphologic remission may still have a large number of residual leukemic cells (potentially up to 1010).

Minimal residual disease (MRD) is currently the most powerful prognostic indicator in Precursor B acute lymphoblastic leukemia (B ALL). MRD analysis can be done by either flow cytometric or molecular techniques. Flow cytometric detection holds potential for wider applicability than molecular techniques because flow cytometric methods for leukemia diagnosis are already established at most cancer centers worldwide.

Flow cytometric detection of MRD is based on the principle that ALL cells express immunophenotypic features that can be used to distinguish them from normal hematopoietic cells, including hematogones and activated lymphocytes commonly referred to as Leukemia associated immunophenotype (LAIP). In virtually all patients with ALL, leukemia-associated immunophenotypes can be defined at diagnosis and then used to monitor MRD during treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • New cases of patients with acute lymphocytic leukemia.
  • Evaluation of markers 15 days after induction.

排除标准

  • Patients died after induction
  • Patients diagnosed as Non Hodgkin Lymphoma.

结局指标

主要结局

Level of expression of markers in acute lymphoblastic leukemia.

时间窗: 1 year

Level of expression of CD66c, CD 123 \& CD 73 in acute lymphocytic leukemia ,the correlation with each other .and with the clinical assessment of patients before and after induction

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

Maureen Farag

Principal Investigator

Assiut University

研究点 (1)

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