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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04018118
Other study ID # 2018_36
Secondary ID 2018-A02624-51
Status Recruiting
Phase
First received
Last updated
Start date May 6, 2019
Est. completion date May 2031

Study information

Verified date February 2023
Source University Hospital, Lille
Contact Guillaume Lefevre, MD
Phone 03 20 44 55 72
Email Guillaume.lefevre@chru-lille.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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, ..)


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date May 2031
Est. primary completion date May 6, 2029
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Biological sample
Additional blood samples for biobanking

Locations

Country Name City State
France Hôpital Roger Salengro, CHU Lille

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Frequency of the evolutionary profiles Frequency of the different evolutionary profiles. 10 years
Secondary Frequency of complications depending of the type of HES Frequency of complications (organ damages) depending on the type of HES (idiopathic, reactive, clonal…). 10 years
Secondary Frequency of organ damage profiles before and after 18 years old. Describe the characteristics of pediatrics HE/HES vs adult HE/HES. 10 years
Secondary Frequency of clinical complications profiles before and after 18 years old. Clinical characteristics of pediatrics HE/HES vs adult HE/HES. 10 years
Secondary Frequency of HLA alleles and variants / mutations on other genes of HE/HES Predisposing factors in HE/HES by various genomic approaches 10 years
Secondary Serum biomarkers to explore Potential predisposing factors in HE/HES: serum markers predictive of interest in eosinophilopoiesis (IL5), tissue homing (eotaxins, etc.) 10 years
Secondary Difference in Membrane activation markers of HE patients (asymptomatic) versus SHE (symptomatic). Predisposing factors in HE/HES by various genomic approaches 10 years
Secondary Difference in Eosinophilic gene expression profiles of HE patients (asymptomatic) versus SHE (symptomatic). Predisposing factors in HE/HES by various genomic approaches 10 years
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