EosinophiliaCOHESIONNCT04018118
Natural History of Hypereosinophilia and Hypereosinophilic Syndromes
An observational study of Eosinophilia and Hypereosinophilic Syndrome, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eosinophilia, Hypereosinophilic Syndrome
- What is being tested?
- Biological sample
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 6 May 2019to May 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Hypereosinophilia and Hypereosinophilic Syndromes
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Roger Salengro, CHU
Lille
Guillaume Lefevre, MD,PhD
About this study
Official title: 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, ..)
Read the 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 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
- Eosinophilia, Hypereosinophilic Syndrome
- Being tested
- Biological sample
- Keywords
- Eosinophilia, Hypereosinophilia, Hypereosinophilic Syndrome
- Medical subject headings
- Eosinophilia, Hypereosinophilic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological sampleBiological
Additional blood samples for biobanking
| Study group | Role | What they receive |
|---|---|---|
| Eosinophilia/Hypereosinophilic syndrome | patient with eosinophilia and/or hypereosinophilic syndrome Receives: Biological: Biological sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (8)
Frequency of the evolutionary profiles
Frequency of the different evolutionary profiles.
Measured: 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…).
Measured: 10 years
Frequency of organ damage profiles before and after 18 years old.
Describe the characteristics of pediatrics HE/HES vs adult HE/HES.
Measured: 10 years
Frequency of clinical complications profiles before and after 18 years old.
Clinical characteristics of pediatrics HE/HES vs adult HE/HES.
Measured: 10 years
Frequency of HLA alleles and variants / mutations on other genes of HE/HES
Predisposing factors in HE/HES by various genomic approaches
Measured: 10 years
Serum biomarkers
to explore Potential predisposing factors in HE/HES: serum markers predictive of interest in eosinophilopoiesis (IL5), tissue homing (eotaxins, etc.)
Measured: 10 years
Difference in Membrane activation markers of HE patients (asymptomatic) versus SHE (symptomatic).
Predisposing factors in HE/HES by various genomic approaches
Measured: 10 years
Difference in Eosinophilic gene expression profiles of HE patients (asymptomatic) versus SHE (symptomatic).
Predisposing factors in HE/HES by various genomic approaches
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start6 May 2019
- Primary completion6 May 2029 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EosinophiliaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Lefevre, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018118
- Sponsor's protocol ID
- 2018_36
- Other IDs
- 2018-A02624-51
- Acronym
- COHESION
- Status last verified
- Feb 2026
- First submitted
- 15 May 2019
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39757773
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Clinical Profiles of Patients Followed for Chronic Hypereosinophilia and/or Hypereosinophilic Syndrome by the Creation of a National Cohort
- ClinicalTrials.gov ID
- NCT04018118
- Acronym / sponsor ID
- COHESION / 2018_36
- Conditions
- Eosinophilia, Hypereosinophilic Syndrome
- Keywords
- Eosinophilia, Hypereosinophilia, Hypereosinophilic Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 6 May 2019 (actual)
- Primary completion
- 6 May 2029 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eosinophilia/Hypereosinophilic syndrome | – | Biological: Biological samplepatient with eosinophilia and/or hypereosinophilic syndrome |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Hypereosinophilia and Hypereosinophilic Syndromes
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological sampleAdditional blood samples for biobanking | Biological | Eosinophilia/Hypereosinophilic syndrome |
Primary outcome
Frequency of the different clinical manifestations at time of diagnosis and during follow-up of the hypereosinophilic syndrome (HES)
Time frame: 10 years
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.
8 secondary outcomes
Frequency of the evolutionary profiles
Time frame: 10 years
Frequency of complications depending of the type of HES
Time frame: 10 years
Frequency of organ damage profiles before and after 18 years old.
Time frame: 10 years
Frequency of clinical complications profiles before and after 18 years old.
Time frame: 10 years
Frequency of HLA alleles and variants / mutations on other genes of HE/HES
Time frame: 10 years
Serum biomarkers
Time frame: 10 years
Difference in Membrane activation markers of HE patients (asymptomatic) versus SHE (symptomatic).
Time frame: 10 years
Difference in Eosinophilic gene expression profiles of HE patients (asymptomatic) versus SHE (symptomatic).
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Results publication: PubMed 39757773Lefevre 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillaume Lefevre principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilia and Hypereosinophilic Syndrome, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Lefevre, MD (03 20 44 55 72 ext. +33, Guillaume.lefevre@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of the different clinical manifestations at time of diagnosis and during follow-up of the hypereosinophilic syndrome (HES) (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04018118, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.