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Natural History of Hypereosinophilia and Hypereosinophilic Syndromes (COHESION)

U

University Hospital, Lille

Status

Enrolling

Conditions

Hypereosinophilic Syndrome
Eosinophilia

Treatments

Biological: Biological sample

Study type

Observational

Funder types

Other

Identifiers

NCT04018118
2018_36
2018-A02624-51 (Registry Identifier)

Details and patient eligibility

About

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, ..)

Full 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.

Enrollment

600 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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)

Trial design

600 participants in 1 patient group

Eosinophilia/Hypereosinophilic syndrome
Description:
patient with eosinophilia and/or hypereosinophilic syndrome
Treatment:
Biological: Biological sample

Trial contacts and locations

1

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Central trial contact

Guillaume Lefevre, MD

Data sourced from clinicaltrials.gov

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