跳至主要内容
临床试验/NCT04573686
NCT04573686Unknown不适用

Prognostic Value of Serum Erythropoietin Level,Ferritin Level and Fibrinogen in Adult Low Risk MDS

Assiut University0 个研究点目标入组 50 人开始时间: 2021年1月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
50
主要终点
effect of erythropoietin on MDS prognosis

研究概览

简要总结

  1. assessment of the penefit of erythropoietin administration in decreasing the frequency of blood transfusion in adult low risk MDS
  2. assessement of the clinical significance of the relationship between hyperfibrinogenemia and the prognosis of patients with low risk MDS
  3. assessement of the association between serum ferritin levels and patient _reported aspects and symptomes

详细描述

The myelodysplastic syndromes (MDSs) are clonal hematopoietic stem cell disorders characterized by progressive peripheral cytopenia due to ineffective hematopoiesis and a variable risk of transformation into acute myeloid leukemia (AML) .

Clinically, they can range from variable grade of cytopenia to forms not different from AML.

World Health Organization (WHO) MDS classifications from 2002:

included refractory anemia (RA), refractory anemia with ring sideroblasts (RARS), refractory cytopenia with multilineage dysplasia (RCMD), RCMD and ring sideroblasts (RCMDRS), refractory anemia with excess blasts (RAEB), and MDS associated with isolated del(5q) The most recent 2016 WHO MDS classifications are slightly different and include MDS with single lineage or multilineage dysplasia, MDS with ring sideroblasts and single or multilineage dysplasia, MDS with excess blasts, and MDS with isolated del(5q) .

A key first-line treatment option for many patients with symptomatic anemia associated with lower-risk MDS is erythropoiesis-stimulating agents (ESAs) (e.g., epoetin alpha ordarbepoetinalpha),whichmayalsobecombinedwithgranulocyte colony-stimulating factor (G-CSF At least, four mechanisms are recognized to underlie pancytopenia in myelodysplastic syndromes. Based on ferrokinetic studies two distinct mechanisms can be distinguished: (1) hypoproliferative suppressed erythropoiesis and (2) hypoproliferative/ineffective erythropoiesis,The predictive variables for ESAs response in MDS should be divided into biological and clinical variables. Biological variables include: endogenous erythropoietin levels < 500 U/L and marrow blasts < 10%, IPSS low INT-1, diagnosis of refractory anemia, and normal karyotype. On clinical plane, transfusion independence and short duration of disease are positive prognostic factors of response to ESAS .

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
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • the participants are :adult low risk(IPSS score (2-3) myelodysplastic patients with median age (40-60)

排除标准

  • patients with hiigh and intermediate risk MDS

结局指标

主要结局

effect of erythropoietin on MDS prognosis

时间窗: 1 year

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

Asmaa Gamal Mohamed Abd Elaal

resident doctor

Assiut University

相似试验