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临床试验/NCT02791217
NCT02791217Unknown不适用

Identification of Hematological Malignancies and Therapy Predication Using microRNAs as a Diagnostic Tool

Assuta Medical Center0 个研究点目标入组 100 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
Molecular characteristics (by GEP, miRNA)

研究概览

简要总结

MiRNAs are small (~19-25 nucleotides) non-coding RNA molecules that bind to mRNA in a sequence-specific manner. MiRNAs regulate gene expression at the post-transcriptional level. MiRNAs regulate critical cell processes such as metabolism, apoptosis, development, cell cycle, hematopoietic differentiation and have been implicated in the development and progression of several types of cancers, including hematological malignancies. Over-expression, amplification and/or deletion of miRNAs and miRNA-mediated modification of epigenetic silencing can all lead to oncogenic pathways.

Hematologic cancers, which are caused by the malignant transformation of bone marrow cells and the lymphatic system, are usually divided into three major clusters: leukemia, lymphoma, and multiple myeloma. To date, some of the hematological malignancies are very aggressive that early diagnosis is essential for improving prognosis and increasing survival rates. However, current diagnostic methods have various limitations, such as insufficient sensitivity, specificity, it is also time-consuming, costly, and requires a high level of expertise, which limits its application in clinical contexts. Thus, development of new biomarkers for the early detection and relapse of hematological malignancies is desirable.

Some of the innate properties of miRNAs make them highly attractive as potential biomarkers. MiRNAs can be readily detected in small volume samples using specific and sensitive quantitative real-time PCR; they have been isolated from most body fluids, including serum, plasma, urine, saliva, tears and semen and are known to circulate in a highly stable, cell-free form. They are highly conserved between species, allowing the use of animal models of disease for pre-clinical studies. Furthermore, tumor cells have been shown to release miRNAs into the circulation and profiles of miRNAs are altered in the plasma and/or serum of patients with cancer. A growing number of publications confirm that miRNAs can be a useful biomarker for hematological malignancies diagnosis and progression.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Newly diagnose patients with: Diffused large B cell lymphoma, Follicular lymphoma, Multiple myeloma and Hodgkin lymphoma.
  • Patients after chemotherapy (5-30 days).
  • Above age 18.

排除标准

  • Non-HIV/HCV/HBV Below age 18.

结局指标

主要结局

Molecular characteristics (by GEP, miRNA)

时间窗: 1 year

次要结局

  • Event free survival (EFS)(0-5 years)
  • Overall survival (OS)(0-5 years)

研究者

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

shpilberg ofer

Head of hematology department

Assuta Medical Center

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