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RecruitingNCT04018118COHESIONUpdated Feb 20, 2026

Natural History of Hypereosinophilia and Hypereosinophilic Syndromes

An observational study in Eosinophilia and Hypereosinophilic Syndrome, sponsored by University Hospital, Lille. Recruiting at 1 site in France. Per ClinicalTrials.gov, last updated 2026-02-20.

Sponsored by University Hospital, Lille · Observational

From the registry’s dates

  • Started May 2019; still recruiting 7 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Sex
All
01

Study 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, ..)

Read the 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.

02

Conditions studied

  • Eosinophilia
  • Hypereosinophilic Syndrome

Keywords

  • Eosinophilia
  • Hypereosinophilia
  • Hypereosinophilic Syndrome
03

In context

Eosinophilia

66 studies on the registry are indexed under Eosinophilia; 14 are open to participants now.

This study's planned enrollment of 600 is above the median of 225 across 24 observational studies indexed under Eosinophilia.

Browse Eosinophilia studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with Hypereosinophilia and Hypereosinophilic Syndromes

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

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)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Eosinophilia/Hypereosinophilic syndrome

    patient with eosinophilia and/or hypereosinophilic syndrome

    Biological: Biological sample

Interventions

  • BiologicalBiological sample

    Additional blood samples for biobanking

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What researchers measure

Primary outcomes

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

    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.

    Time frame: 10 years

Secondary outcomes

  1. Frequency of the evolutionary profiles

    Frequency of the different evolutionary profiles.

    Time frame: 10 years

  2. Frequency of complications depending of the type of HES

    Frequency of complications (organ damages) depending on the type of HES (idiopathic, reactive, clonal…).

    Time frame: 10 years

  3. Frequency of organ damage profiles before and after 18 years old.

    Describe the characteristics of pediatrics HE/HES vs adult HE/HES.

    Time frame: 10 years

  4. Frequency of clinical complications profiles before and after 18 years old.

    Clinical characteristics of pediatrics HE/HES vs adult HE/HES.

    Time frame: 10 years

  5. Frequency of HLA alleles and variants / mutations on other genes of HE/HES

    Predisposing factors in HE/HES by various genomic approaches

    Time frame: 10 years

  6. Serum biomarkers

    to explore Potential predisposing factors in HE/HES: serum markers predictive of interest in eosinophilopoiesis (IL5), tissue homing (eotaxins, etc.)

    Time frame: 10 years

  7. Difference in Membrane activation markers of HE patients (asymptomatic) versus SHE (symptomatic).

    Predisposing factors in HE/HES by various genomic approaches

    Time frame: 10 years

  8. Difference in Eosinophilic gene expression profiles of HE patients (asymptomatic) versus SHE (symptomatic).

    Predisposing factors in HE/HES by various genomic approaches

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
  • Hôpital Roger Salengro, CHU
    Lille, France
    • Guillaume Lefevre, MD,PhD · Principal investigator
    Recruiting
08

References and documents

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, Leurs A, Lugosi M, Martin M, Melboucy-Belkhir S, Morati-Hafsaoui C, Quemeneur T, Rohmer J, Roy-Peaud F, Sanges S, Schleinitz N, Staumont-Salle D, Taille C, Terriou L, Tieulie N, Koenga JDE, Schwarb L, Panel K, Kahn JE, Groh M; COHESion study group. Hypereosinophilia and Hypereosinophilic Syndromes: First Findings From a Nationwide Multicenter Cohort. Allergy. 2025 Apr;80(4):1100-1110. doi: 10.1111/all.16463. Epub 2025 Jan 5. PubMed 39757773 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04018118
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Jul 12, 2019
Start date
May 6, 2019
Primary completion
May 6, 2029 (estimated)
Completion
May 2031 (estimated)
Last update
Feb 20, 2026

Study contacts

Guillaume Lefevre, MD
Contact
Guillaume.lefevre@chru-lille.fr
03 20 44 55 72 ext. +33
Guillaume Lefevre
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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