Natural History of Hypereosinophilia and Hypereosinophilic Syndromes (COHESION)

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

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, ..)

Study Overview

• Status: Recruiting
• Conditions: Eosinophilia; Hypereosinophilic Syndrome
• Intervention / Treatment: Biological: Biological sample

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.

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Recruiting
    • Hôpital Roger Salengro, CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Hypereosinophilia and Hypereosinophilic Syndromes

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Eosinophilia/Hypereosinophilic syndrome; patient with eosinophilia and/or hypereosinophilic syndrome	Biological: Biological sample; Additional blood samples for biobanking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 6, 2019
• Primary Completion (ANTICIPATED): May 6, 2029
• Study Completion (ANTICIPATED): May 1, 2031

Study Registration Dates

• First Submitted: May 15, 2019
• First Submitted That Met QC Criteria: July 10, 2019
• First Posted (ACTUAL): July 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Hypereosinophilic Syndrome; Hypereosinophilia; Eosinophilia
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Hematologic Diseases; Leukocyte Disorders; Syndrome; Eosinophilia; Hypereosinophilic Syndrome
• Other Study ID Numbers: 2018_36; 2018-A02624-51 (REGISTRY: ID-RCB - ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No