NCT04003220招募中不适用
Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker
University Hospital, Bordeaux4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年9月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Measure of clonality in patients with ICTUS
研究概览
简要总结
It is a translational research study with mechanistical objectives and including biological samples of patients with thrombocytopenia
详细描述
This study is a prospective study to collect blood, bone marrow and hair bulb from patients with thrombocytopenia, to better understand the mechanism of idiopathic chronic thrombocytopenia of undetermined significance (ICTUS)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-80
- •Nosological criteria for thrombocytopenic patients:
- •ICTUS: acquired thrombocytopenia lasting>6 months, without feature of dysimmunity (antiplatelet Ab, or anti nuclear Ab, anti ENA Ab, ANCA, anti-CCP Ab, cryoglobulinemia), normal bone marrow examination, absence of other thrombocytopenia in the family. All ICTUS patients included in the study will thus have a bone marrow aspiration.
- •ITP: Diagnosis of ITP is made according to the international ITP consensus (diagnostic criteria of Rodeghiero){Provan, 2010 #18}, knowing that a presumptive diagnosis of ITP is made when the history, physical examination, complete blood count, and examination of the peripheral blood smears do not suggest other etiologies for the thrombocytopenia. There is no "gold standard" test that can reliably establish the diagnosis. We are concerned that this group of patients may include ICTUS patients.
- •ITP with immunological features: ITP with detectable anti-platelet antibodies (Ab) and/or autoimmunity (anti nuclear Ab, anti ENA Ab, ANCA, anti-CCP Ab, cryoglobulinemia), and/or previously responsive to immunomodulatory ITP-directed therapies (steroids, intravenous Immunoglobulin, rituximab, splenectomy). We will use these patients as non-ICTUS, ITP positive controls.
- •Thrombocytopenic myelodysplasia: platelets <150 G/l and diagnosis of myelodysplasia according to the WHO classification (abnormal bone marrow features).
- •Healthy controls: patients with normal blood counts undergoing cardiovascular surgery for valve replacement, or healthy bone-marrow donors.
- •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
- •Age under 18 or over 80
- •Persons placed under judicial protection,
- •Persons participating in another research including a period of exclusion still in course
- •Persons in emergency situation,
- •Pregnant or nursing women,
- •Women of childbearing age who do not benefit from effective contraception (HAS criteria),
- •Brain death or deceased persons,
- •Person who doesn't speak French, doesn't read it, doesn't write it, and doesn't have a schooling in France.
结局指标
主要结局
Measure of clonality in patients with ICTUS
时间窗: Day 1
identification of mutations in genes known to be involved in clonal expansion
次要结局
未报告次要终点
研究者
研究点 (4)
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