Study of Clinical Profiles of Patients Followed for Chronic Hypereosinophilia and/or Hypereosinophilic Syndrome by the Creation of a National Cohort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Frequency of the different clinical manifestations at time of diagnosis and during follow-up of the hypereosinophilic syndrome (HES)
研究概览
简要总结
Unexplained chronic hypereosinophilia (HE) and hypereosinophilic syndromes (HES) are heterogeneous regarding the organ involvements (heart, lungs, skin, .. or none), the evolutionary profiles, the response to treatments.
Underlying mechanisms are largely unknown and may associate genetic predisposing factors (germinal ? somatic?), environmental factors (alimentation, tobacco use, hormones, infections, ..) The COHESion study aims to study all clinical and biological characteristics of HE/HES patients and their evolutionary profiles, with a focus on genetic factors and the mechanisms supporting transitory or persistant chronic HE/HES (in absence of any well identified extrinsic trigger like drugs, parasitosis, ..)
详细描述
There is currently no data on the natural history of unexplained chronic hypereosinophilia (HE) and hypereosinophilic syndromes (HES). Clinical practice shows that HE/SHE patients can present 4 evolutionary profiles:
A. a single flare-up of their disease, with favourable evolution spontaneously or under corticosteroid therapy, without further recurrence B. recurrent flare-ups with a variable free interval of several months to several years, with or without persistent eosinophilia between flare-ups C. a chronic disease requiring the continuation of a substantive treatment D. chronic asymptomatic HE for years: the mechanisms involved in the occurrence of possible organ damage are unknown
The primary objective of the study is to describe the frequency of the different clinical manifestations during the diagnostic and follow-up of the hypereosinophilic syndrome (HES). The primary endpoint is the frequency of the different clinical manifestations and/or organs damage related to eosinophilia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or Women of any age :
- •With the diagnosis criteria of hyperosinophlia OR hypereosinophilic syndrome OR specific organ eosinophilic disease according to the consensus conference of the International Cooperative Working Group on Eosinophil Disorders (ICOG-EO)
- •With an AEC > 1500/mm3 or organ damage related to the presence of eosinophils in the tissues or organs whatever the context (idiopathic, clonal or reactive, including drug-related, parasitic or allergic)
- •HES diagnosis since 2005/01/01
- •Patients socially insured
- •Patient who agreed to participate to the study, its proceedings and duration.
排除标准
- •Known HIV infection
- •Not socially insured
- •Person unable to receive a enlighten information
- •Person who refuse to sign the consent
- •Persons deprived of their liberty
- •Persons benefiting from a system of legal protection (tutelage / guardianship)
研究组 & 干预措施
Eosinophilia/Hypereosinophilic syndrome
patient with eosinophilia and/or hypereosinophilic syndrome
干预措施: Biological sample (Biological)
结局指标
主要结局
Frequency of the different clinical manifestations at time of diagnosis and during follow-up of the hypereosinophilic syndrome (HES)
时间窗: 10 years
The primary objective of the study is to describe the frequency of the different clinical manifestations at diagnosis and during follow-up of the hypereosinophilic syndrome (HES/HE). The primary endpoint is the frequency of the different clinical manifestations and/or organs damage related to hypereosinophilia.
次要结局
- Difference in Eosinophilic gene expression profiles of HE patients (asymptomatic) versus SHE (symptomatic).(10 years)
- Frequency of organ damage profiles before and after 18 years old.(10 years)
- Frequency of the evolutionary profiles(10 years)
- Difference in Membrane activation markers of HE patients (asymptomatic) versus SHE (symptomatic).(10 years)
- Frequency of clinical complications profiles before and after 18 years old.(10 years)
- Frequency of HLA alleles and variants / mutations on other genes of HE/HES(10 years)
- Serum biomarkers(10 years)
- Frequency of complications depending of the type of HES(10 years)