Natural History of Hypereosinophilia and Hypereosinophilic Syndromes

Recruiting

• Conditions: Eosinophilia; Hypereosinophilic Syndrome
• Interventions: Biological: Biological sample

• Registration Number: NCT04018118
• Lead Sponsor: University Hospital, Lille

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.

Study Timeline

• Study Start: 2019-05-06
• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-07-10
• Study First Posted: 2019-07-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08
• Primary Completion: 2029-05-06
• Study Completion: 2031-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Eosinophilia/Hypereosinophilic syndrome	Biological sample	patient with eosinophilia and/or hypereosinophilic syndrome

Primary Outcome Measures

Name	Time	Method
Frequency of the different clinical manifestations at time of diagnosis and during follow-up of the hypereosinophilic syndrome (HES)	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.

Secondary Outcome Measures

Name	Time	Method
Difference in Eosinophilic gene expression profiles of HE patients (asymptomatic) versus SHE (symptomatic).	10 years	Predisposing factors in HE/HES by various genomic approaches
Frequency of the evolutionary profiles	10 years	Frequency of the different evolutionary profiles.
Frequency of organ damage profiles before and after 18 years old.	10 years	Describe the characteristics of pediatrics HE/HES vs adult HE/HES.
Difference in Membrane activation markers of HE patients (asymptomatic) versus SHE (symptomatic).	10 years	Predisposing factors in HE/HES by various genomic approaches
Frequency of complications depending of the type of HES	10 years	Frequency of complications (organ damages) depending on the type of HES (idiopathic, reactive, clonal...).
Frequency of clinical complications profiles before and after 18 years old.	10 years	Clinical characteristics of pediatrics HE/HES vs adult HE/HES.
Frequency of HLA alleles and variants / mutations on other genes of HE/HES	10 years	Predisposing factors in HE/HES by various genomic approaches
Serum biomarkers	10 years	to explore Potential predisposing factors in HE/HES: serum markers predictive of interest in eosinophilopoiesis (IL5), tissue homing (eotaxins, etc.)

Trial Locations

Locations (1)

Hôpital Roger Salengro, CHU; 🇫🇷 Lille, France