NCT04018118

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, ..)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
61mo left

Started May 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
May 2019May 2031

Study Start

First participant enrolled

May 6, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2029

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2031

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

10 years

First QC Date

May 15, 2019

Last Update Submit

February 18, 2026

Conditions

Keywords

EosinophiliaHypereosinophiliaHypereosinophilic Syndrome

Outcome Measures

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.

    10 years

Secondary Outcomes (8)

  • Frequency of the evolutionary profiles

    10 years

  • Frequency of complications depending of the type of HES

    10 years

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

    10 years

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

    10 years

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

    10 years

  • +3 more secondary outcomes

Study Arms (1)

Eosinophilia/Hypereosinophilic syndrome

patient with eosinophilia and/or hypereosinophilic syndrome

Biological: Biological sample

Interventions

Additional blood samples for biobanking

Eosinophilia/Hypereosinophilic syndrome

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Hypereosinophilia and Hypereosinophilic Syndromes

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Roger Salengro, CHU

Lille, France

RECRUITING

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Blood.

MeSH Terms

Conditions

EosinophiliaHypereosinophilic Syndrome

Condition Hierarchy (Ancestors)

Leukocyte DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Guillaume Lefevre

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2019

First Posted

July 12, 2019

Study Start

May 6, 2019

Primary Completion (Estimated)

May 6, 2029

Study Completion (Estimated)

May 1, 2031

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations