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临床试验/NCT04708444
NCT04708444Unknown不适用

Prognostic Value of CD318 in Acute Myeloid Leukemia Patients at Assiut University Hospital

Shimaa Arafa Ibrahim0 个研究点目标入组 100 人开始时间: 2021年3月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
Prognosis of CD318 in AML

研究概览

简要总结

We will focus on the prognostic value of CD318 in acute myeloid leukemia patients at Assiut University Hospital

详细描述

Acute myeloid leukemia (AML) is a disease with high mortality and variable prognosis . It remains a disease with a highly variable outcome depending on the exact footprint of the AML .Although many patients with AML have a response to induction therapy ,refractory disease is common and relapse represents the major cause of treatment failure .In 2016 the World Heath Organization published revisions to classification of Myeloid Neoplasms and Acute leukemias .Well-established prognostic factors are cytogenetic aberrations such as t(8;21), inv(16), and t(15;17) as well as mutated IDH1/2, NPM1, and FLT3 genes but only few markers can specifically predict the outcome after HSCT .Immunophenotyping via flowcytometry comprises an additional fast technique to predict outcome in AML, although only few markers are yet established as prognostic factors in clinical routine diagnosis, despite the fact that new and rapidly available markers are needed to improve the treatment decisions in AML patients. This is even more since starting therapy in AML patients must be initiated immediately after diagnosis . Overall mortality from AML is high and treatment should be initiated within hours after first diagnosis . In hematopoietic cells,CD318 has been identified as stem cell marker for both benign and malignant progenitor cells. CD318+ bone marrow or cord blood-derived cells have been shown to be capable to initiate multi-lineage hematopoiesis in vitro and in vivo .CD318 (CUB domain containing protein-1, CDCP1) is a highly glycosylated single pass transmembrane protein express endomesenchymal and neural stem cells and fibroblasts and hematopoietic.Overexpression of CD318 has been recently correlated with poor overall survival(OS) in colonic ,breast ,renal, hepatocellular ,and pancreatic Carcinoma.possibly due to its role in metastasis formation via interaction with integrins and anti-apoptotic signaling via Akt. Of AML blasts, pronounced CD318 expression has been observed on the immature CD34+CD133+ leukemic cells subset implicated to be enriched for leukemic stem. However, the impact of CD318 on survival in hematological malignancies has so far not been analyzed. Study done by Jonas S et al showed 57% of AML patients expressed relevant CD318 levels and a significant correlation of CD 318 surface levels with prognosis was observed . In our study investigators will use flowcytometry to detect CD318 on AML blasts and correlate it with disease course and outcome.

研究设计

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

入排标准

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

入选标准

  • newly diagnosed AML patients
  • Age more than 18 years
  • Patients not starting chemotherapy yet
  • Primary AML
  • Secondary AML on top of MDS or myeloproliverative noeplasms

排除标准

  • Refractory AML patients
  • Relapsed AML patients

结局指标

主要结局

Prognosis of CD318 in AML

时间窗: Throughout study completion, average of one year

Flowcytometric analysis of AML blasts for CD318 and correlate it with disease course (progression free survival) and disease outcome (overall survival) . Also correlate level of expression of CD318 with response to treatment given ( intensive chemotherapy, hypomethylating agents, alternative palliative therapy. CD318 to detect level of expression and correlate it with disease course (progression free survival) and outcome (overall survival) .

次要结局

未报告次要终点

研究者

发起方
Shimaa Arafa Ibrahim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shimaa Arafa Ibrahim

Assistant lecturer

Assiut University

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