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临床试验/NCT03907670
NCT03907670Unknown不适用

Clinical and Immunological Outcome in Chronic Myloid Leukemic Patients Treated With Tyrosine Kinase Inhibitor: Assuit University Hospitals Insight

Assiut University0 个研究点目标入组 45 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
45
主要终点
assessment of CML patients receiving tyrosine kinase inhibitors

研究概览

简要总结

The aim of the study is to assesse the levels of various biomarkers, specifically interleukin (IL)-6, platelet-derived microparticles (PDMPs), 11, 12 soluble vascular cell adhesion molecule 1 (sVCAM-1), transforming growth factor (TGF) β1, and sCTLA-4, in TKI-treated patients with CML.

To measure the fluctuations in the levels of sCTLA-4, TGFβ1, and PDMPs, and to clarify the clinical significance of these biomarkers during TKI therapy in patients with CML..

详细描述

Chronic myelogenous leukemia (CML) is a myeloproliferative disorder in which leukemic cells display the Philadelphia chromosome generated from a reciprocal t(9:22) (q34:q11) translocation.1 The chromosome 9 and chromosome 22 transposal of t (9:22) and (q34:q11) causes the cancer gene C-ABL at 9q34 to link with the BCR gene at 22q11, forming the BCR-ABL gene on chromosome 22.2 CML is presented by constitutional complaints (fatigue, weight loss, and fever), those related to splenomegaly (abdominal fullness, anorexia, abdominal pain, and early satiety) and bleeding tendency (easy bruising or bleeding) are most frequent symptoms. Splenomegaly (≥ 95%), sternal tenderness, hepatomegaly, purpura, and retinal hemorrhage are commonly reported signs at physical exam. To diagnose CML, doctors use a variety of tests to analyze the blood and marrow cells.

*Complete Blood Count (CBC). This test is used to measure the number and types of cells in the blood. People with CML often have:

  • Decreased hemoglobin concentration
  • Increased white blood cell count, often to very high levels
  • Possible increase or decrease in the number of platelets depending on the severity

Blood cells are stained (dyed) and examined with a light microscope. These samples show:

  • Specific pattern of white blood cells
  • Small proportion of immature cells (leukemic blast cells and promyelocytes)
  • Larger proportion of maturing and fully matured white blood cells (myelocytes and neutrophils).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Newly diagnosed CML patients
  • Receive TKI treatment (imatinib, nilotinib, dasatinib) selected among those admitted to the investigator's hospital.
  • Ageing group 20yr up to 80 yr.

排除标准

  • CML patients who previously treated with TKI.
  • Age below 20 yrs.

结局指标

主要结局

assessment of CML patients receiving tyrosine kinase inhibitors

时间窗: 6 months

Assesse the levels of various biomarkers, especifically 1-interleukin (IL)-6, 2- platelet-derived microparticles (PDMPs),3- 17-20 soluble vascular cell adhesion molecule 1(sVCAM-1),4- Transforming growth factor (TGF) β1, and sCTLA-4, in TKI-treated patients with CML

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

Esraa Nageh Adam

principal investigator

Assiut University

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