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Natural History of Hypereosinophilia and Hypereosinophilic Syndromes

Study of Clinical Profiles of Patients Followed for Chronic Hypereosinophilia and/or Hypereosinophilic Syndrome by the Creation of a National Cohort

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04018118
Acronym
COHESION
Enrollment
600
Registered
2019-07-12
Start date
2019-05-06
Completion date
2031-05-01
Last updated
2026-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilia, Hypereosinophilic Syndrome

Keywords

Eosinophilia, Hypereosinophilia, Hypereosinophilic Syndrome

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.

Interventions

Additional blood samples for biobanking

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Frequency of the different clinical manifestations at time of diagnosis and during follow-up of the hypereosinophilic syndrome (HES)10 yearsThe 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

MeasureTime frameDescription
Frequency of the evolutionary profiles10 yearsFrequency of the different evolutionary profiles.
Frequency of complications depending of the type of HES10 yearsFrequency of complications (organ damages) depending on the type of HES (idiopathic, reactive, clonal…).
Frequency of organ damage profiles before and after 18 years old.10 yearsDescribe the characteristics of pediatrics HE/HES vs adult HE/HES.
Frequency of clinical complications profiles before and after 18 years old.10 yearsClinical characteristics of pediatrics HE/HES vs adult HE/HES.
Frequency of HLA alleles and variants / mutations on other genes of HE/HES10 yearsPredisposing factors in HE/HES by various genomic approaches
Serum biomarkers10 yearsto explore Potential predisposing factors in HE/HES: serum markers predictive of interest in eosinophilopoiesis (IL5), tissue homing (eotaxins, etc.)
Difference in Membrane activation markers of HE patients (asymptomatic) versus SHE (symptomatic).10 yearsPredisposing factors in HE/HES by various genomic approaches
Difference in Eosinophilic gene expression profiles of HE patients (asymptomatic) versus SHE (symptomatic).10 yearsPredisposing factors in HE/HES by various genomic approaches

Countries

France

Contacts

CONTACTGuillaume Lefevre, MD
Guillaume.lefevre@chru-lille.fr03 20 44 55 72
PRINCIPAL_INVESTIGATORGuillaume Lefevre

University Hospital, Lille

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026