跳至主要内容
临床试验/NCT04005638
NCT04005638招募中不适用

Biological Bank for the Patients Followed in a Constitutive Reference Center for Autoimmune Cytopenia

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年2月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Number of patients with autoimmune cytopenia at diagnosis, or followed but not treated with a biological library (serum, plasma, DNA)

研究概览

简要总结

The Internal Medicine Department of Haut-Lévêque Hospital (Pr E LAZARO, Pr JL PELLEGRIN, Pr JF VIALLARD) was accredited in 2017 by the Ministry of Health as a Constitutive Reference Center for Autoimmune Cytopenia. The investigators wish to launch new research projects in autoimmune cytopenia and propose a translational and fundamental research based on collaboration between the clinical department, the biological resource center and the CNRS and INSERM research units ("Bedside to the Bench Strategy"). Thus, in the perspective of future research work, it seems imperative to set up a biological bank for the patients followed in our Reference Center.

详细描述

Our department follows about 350 patients with immune thrombocytopenia (ITP), 50 with autoimmune hemolytic anemia (AHA), and about thirty patients for autoimmune neutropenia and erythroblastopenia. The number of new patients per year is about 50. The investigators are working since several years on different research topics concerning ITP and AHA.

In the field of ITP, the investigators are working on abnormalities of megakaryopoiesis present in a particular subgroup of patients. The investigators seek to identify the molecular mechanisms underlying this platelet-forming disorder. This research is done within the INSERM U1034 unit of the University of Bordeaux.

In AHA, The investigators are working on the role of regulatory CD8+ T lymphocytes and the interest of low doses of Interleukin-2 in their treatment. This part is carried out within the CNRS unit UMR 5164 ImmunoConcept. The biological collection the investigators wish to create will be available for basic research projects and may be available to the pharmaceutical industry as part of the development of new molecules.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Patients over 16 years old.
  • Patients with autoimmune cytopenia according to the definitions reported in the latest update of the French National Care Protocol (PNDS 2017).
  • Affiliated person or beneficiary of a social security scheme.
  • Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).

排除标准

  • Positivity for HIV, Hepatitis C or B virus.
  • Pregnant or lactating woman.
  • Patient undergoing treatment for autoimmune cytopenia

研究组 & 干预措施

Autoimmune Cytopenia

干预措施: blood sample (Biological)

Autoimmune Cytopenia

干预措施: urine sample (Biological)

结局指标

主要结局

Number of patients with autoimmune cytopenia at diagnosis, or followed but not treated with a biological library (serum, plasma, DNA)

时间窗: At baseline (Day 0)

次要结局

未报告次要终点

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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