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Natural History of Hypereosinophilia and Hypereosinophilic Syndromes (COHESION)
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, ..)
| Condition or disease | Intervention/treatment |
|---|---|
| Eosinophilia Hypereosinophilic Syndrome | Biological: Biological sample |
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 |
| Estimated Enrollment : | 600 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Study of Clinical Profiles of Patients Followed for Chronic Hypereosinophilia and/or Hypereosinophilic Syndrome by the Creation of a National Cohort |
| Actual Study Start Date : | May 6, 2019 |
| Estimated Primary Completion Date : | May 6, 2029 |
| Estimated Study Completion Date : | May 2031 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
Eosinophilia/Hypereosinophilic syndrome
patient with eosinophilia and/or hypereosinophilic syndrome
|
Biological: Biological sample
Additional blood samples for biobanking
|
- 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.
- Frequency of the evolutionary profiles [ Time Frame: 10 years ]Frequency of the different evolutionary profiles.
- Frequency of complications depending of the type of HES [ Time Frame: 10 years ]Frequency of complications (organ damages) depending on the type of HES (idiopathic, reactive, clonal…).
- Frequency of organ damage profiles before and after 18 years old. [ Time Frame: 10 years ]Describe the characteristics of pediatrics HE/HES vs adult HE/HES.
- Frequency of clinical complications profiles before and after 18 years old. [ Time Frame: 10 years ]Clinical characteristics of pediatrics HE/HES vs adult HE/HES.
- Frequency of HLA alleles and variants / mutations on other genes of HE/HES [ Time Frame: 10 years ]Predisposing factors in HE/HES by various genomic approaches
- Serum biomarkers [ Time Frame: 10 years ]to explore Potential predisposing factors in HE/HES: serum markers predictive of interest in eosinophilopoiesis (IL5), tissue homing (eotaxins, etc.)
- Difference in Membrane activation markers of HE patients (asymptomatic) versus SHE (symptomatic). [ Time Frame: 10 years ]Predisposing factors in HE/HES by various genomic approaches
- Difference in Eosinophilic gene expression profiles of HE patients (asymptomatic) versus SHE (symptomatic). [ Time Frame: 10 years ]Predisposing factors in HE/HES by various genomic approaches
Biospecimen Retention: Samples With DNA
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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)
| Contact: Guillaume Lefevre, MD | 03 20 44 55 72 ext +33 | Guillaume.lefevre@chru-lille.fr |
| France | |
| Hôpital Roger Salengro, CHU | Recruiting |
| Lille, France | |
| Principal Investigator: Guillaume Lefevre, MD,PhD | |
| Principal Investigator: | Guillaume Lefevre | University Hospital, Lille |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 15, 2019 | ||||
| First Posted Date | July 12, 2019 | ||||
| Last Update Posted Date | August 26, 2020 | ||||
| Actual Study Start Date | May 6, 2019 | ||||
| Estimated Primary Completion Date | May 6, 2029 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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.
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Natural History of Hypereosinophilia and Hypereosinophilic Syndromes | ||||
| Official Title | Study of Clinical Profiles of Patients Followed for Chronic Hypereosinophilia and/or Hypereosinophilic Syndrome by the Creation of a National Cohort | ||||
| Brief 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, ..) |
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| 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. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description:
Blood.
|
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with Hypereosinophilia and Hypereosinophilic Syndromes | ||||
| Condition |
|
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| Intervention | Biological: Biological sample
Additional blood samples for biobanking
|
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| Study Groups/Cohorts | Eosinophilia/Hypereosinophilic syndrome
patient with eosinophilia and/or hypereosinophilic syndrome
Intervention: Biological: Biological sample
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
600 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | May 2031 | ||||
| Estimated Primary Completion Date | May 6, 2029 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04018118 | ||||
| Other Study ID Numbers | 2018_36 2018-A02624-51 ( Registry Identifier: ID-RCB - ANSM ) |
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| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | University Hospital, Lille | ||||
| Study Sponsor | University Hospital, Lille | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | University Hospital, Lille | ||||
| Verification Date | August 2020 | ||||
