Natural History of Hypereosinophilia and Hypereosinophilic Syndromes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biological sample.
- Who it may be relevant to
- Registry conditions: Eosinophilia, Hypereosinophilic Syndrome. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study of Clinical Profiles of Patients Followed for Chronic Hypereosinophilia and/or Hypereosinophilic Syndrome by the Creation of a National Cohort
Overview
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.
Interventions
- Biological Biological sample
Additional blood samples for biobanking
Primary outcome measures
- Frequency of the different clinical manifestations at time of diagnosis and during follow-up of the hypereosinophilic syndrome (HES) [Time frame: 10 years]
Secondary outcome measures (8)
- Frequency of the evolutionary profiles [Time frame: 10 years]
- Frequency of complications depending of the type of HES [Time frame: 10 years]
- Frequency of organ damage profiles before and after 18 years old. [Time frame: 10 years]
- Frequency of clinical complications profiles before and after 18 years old. [Time frame: 10 years]
- Frequency of HLA alleles and variants / mutations on other genes of HE/HES [Time frame: 10 years]
- Serum biomarkers [Time frame: 10 years]
- Difference in Membrane activation markers of HE patients (asymptomatic) versus SHE (symptomatic). [Time frame: 10 years]
- Difference in Eosinophilic gene expression profiles of HE patients (asymptomatic) versus SHE (symptomatic). [Time frame: 10 years]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hôpital Roger Salengro, CHU — Lille
Publications
- Lefevre G, Bleuse S, Puyade M, Moulis G, Neel A, Abisror N, Baudet A, Bonnotte B, Dion J, Dossier A, Grall M, Lifermann F, Limal N, Lioger B, Machelart I, Mohr C, Outh R, Queyrel-Moranne V, Slama B, Trefond L, Abou Chahla W, Ackerman F, Belfeki N, Berezne A, Blade JS, Bouderbala MA, Chebrek S, Cottin V, De Almeida S, De Masson A, Dezoteux F, Goulenok T, Jachiet V, Jouvray M, Latu I, Ledoult E, Leu PMID 39757773
Identifiers
NCT: NCT04018118 · 2018_36 · 2018-A02624-51