Clinical trial NCT04018118: Natural History of Hypereosinophilia and Hypereosinophilic Syndromes
Official title: Study of Clinical Profiles of Patients Followed for Chronic Hypereosinophilia and/or Hypereosinophilic Syndrome by the Creation of a National Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Eosinophilia
Hypereosinophilic Syndrome
Keywords: Eosinophilia
Hypereosinophilia
Hypereosinophilic Syndrome
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Hypereosinophilia and Hypereosinophilic Syndromes

Brief summary: 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, ..)

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Frequency of the different clinical manifestations at time of diagnosis and during follow-up of the hypereosinophilic syndrome (HES)
timeFrame: 10 years
Secondary outcomes:
measure: Frequency of the evolutionary profiles
timeFrame: 10 years
measure: Frequency of complications depending of the type of HES
timeFrame: 10 years
measure: Frequency of organ damage profiles before and after 18 years old.
timeFrame: 10 years
measure: Frequency of clinical complications profiles before and after 18 years old.
timeFrame: 10 years
measure: Frequency of HLA alleles and variants / mutations on other genes of HE/HES
timeFrame: 10 years
measure: Serum biomarkers
timeFrame: 10 years
measure: Difference in Membrane activation markers of HE patients (asymptomatic) versus SHE (symptomatic).
timeFrame: 10 years
measure: Difference in Eosinophilic gene expression profiles of HE patients (asymptomatic) versus SHE (symptomatic).
timeFrame: 10 years
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHU
Study officials:
affiliation: University Hospital, Lille
name: Guillaume Lefevre
role: PRINCIPAL_INVESTIGATOR
References: