Natural History of Hypereosinophilia and Hypereosinophilic Syndromes

Hypereosinophilic Syndrome Clinical Trial

— COHESION  

Official title:

Study of Clinical Profiles of Patients Followed for Chronic Hypereosinophilia and/or Hypereosinophilic Syndrome by the Creation of a National Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04018118
• Other study ID #: 2018_36
• Secondary ID: 2018-A02624-51
• Status: Recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Eosinophilia
• Hypereosinophilic Syndrome
• Syndrome

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