跳至主要内容
临床试验/NCT03421392
NCT03421392已完成不适用

Study of Platelets Sialylation by Flow Cytometry for the Differential Diagnosis of Immunologic and Constitutive Thrombocytopenia: Diagnostic and Prognostic Interest.

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Assess the difference of sialylation between ITP patients and other causes of thrombocytopenia / controls

研究概览

简要总结

Idiopathic thrombocytopenic purpura (ITP) is the most frequent auto-immune cytopenia. There is no specific biological marker and the diagnosis often results from the exclusion of other differential diagnoses, notably inherited thrombocytopenia.

Recent studies have reported an original platelet destruction mechanism in ITP, by antibody-mediated desialylation of membrane proteins. The detection of platelet sialylation can be readily achieved using flow cytometry. This could provide a new biomarker of ITP, useful to ascertain a diagnosis of ITP and guide towards proper patient management.

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

  • Adult patients (>18yo) with a diagnosis of ITP (primary acute, persisting or chronical)
  • Adult patients (>18yo) with a diagnosis of non immunological thrombocytopenia (constitutive thrombocytopenia, myelodysplastic syndrome, chemotherapy-induced thrombocytopenia)
  • Adult patients (>18 yo) without thrombocytopenia
  • Enrolled in a Social Security system
  • Having provided informed consent

排除标准

  • Minor patients (<18 yo)
  • Enrolled in another clinical study
  • Having received corticosteroids or polyvalent immunoglobulins in the past 4
  • weeks or anti-platelet therapy or NSAID during the past 7 days
  • Having received platelet transfusion in the past fortnight
  • With proven iron deficiency
  • With drug-induced immune-allergic thrombocytopenia.
  • Pregnant and breastfeeding women,
  • guardian patients, will be excluded from this population.

结局指标

主要结局

Assess the difference of sialylation between ITP patients and other causes of thrombocytopenia / controls

时间窗: 18 months

a significant decrease in platelets sialylation in ITP patients, measured in flow cytometry with fluorescent Ricinus communis agglutinin

次要结局

  • Prognostic value and therapy(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验