Natural History of Hypereosinophilia and Hypereosinophilic Syndromes

NCT ID: NCT04018118

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-06

Study Completion Date

2031-05-31

Brief Summary

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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

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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.

Conditions

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Eosinophilia Hypereosinophilic Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Eosinophilia/Hypereosinophilic syndrome

patient with eosinophilia and/or hypereosinophilic syndrome

Biological sample

Intervention Type BIOLOGICAL

Additional blood samples for biobanking

Interventions

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Biological sample

Additional blood samples for biobanking

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume Lefevre

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Roger Salengro, CHU

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Guillaume Lefevre, MD

Role: CONTACT

03 20 44 55 72 ext. +33

References

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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.

Reference Type DERIVED
PMID: 39757773 (View on PubMed)

Other Identifiers

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2018-A02624-51

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018_36

Identifier Type: -

Identifier Source: org_study_id

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