Natural History of Hypereosinophilia and Hypereosinophilic Syndromes

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Brief Title

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

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 Type

Observational


Primary Outcome

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

Secondary Outcome

 Frequency of the evolutionary profiles

Condition

Eosinophilia

Intervention

Biological sample

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

600

Start Date

May 6, 2019

Completion Date

May 2031

Primary Completion Date

May 6, 2029

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)
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Guillaume Lefevre, 03 20 44 55 72, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT04018118

Organization ID

2018_36

Secondary IDs

2018-A02624-51

Responsible Party

Sponsor

Study Sponsor

University Hospital, Lille


Study Sponsor

Guillaume Lefevre, Principal Investigator, University Hospital, Lille


Verification Date

July 2019