Natural History of Hypereosinophilia and Hypereosinophilic Syndromes
الكلمات الدالة
نبذة مختصرة
وصف
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.
تواريخ
| آخر التحقق: | 06/30/2019 |
| تم الإرسال لأول مرة: | 05/14/2019 |
| تم إرسال التسجيل المقدر: | 07/09/2019 |
| أول نشر: | 07/11/2019 |
| تم إرسال آخر تحديث: | 07/09/2019 |
| آخر تحديث تم نشره: | 07/11/2019 |
| تاريخ بدء الدراسة الفعلي: | 05/05/2019 |
| تاريخ الإنجاز الأساسي المقدر: | 05/05/2029 |
| التاريخ المتوقع لانتهاء الدراسة: | 04/30/2031 |
حالة أو مرض
التدخل / العلاج
Biological: Eosinophilia/Hypereosinophilic syndrome
مرحلة
مجموعات الذراع
| ذراع | التدخل / العلاج |
|---|---|
| Eosinophilia/Hypereosinophilic syndrome patient with eosinophilia and/or hypereosinophilic syndrome | Biological: Eosinophilia/Hypereosinophilic syndrome Additional blood samples for biobanking |
معايير الأهلية
| الأجناس المؤهلة للدراسة | All |
| طريقة أخذ العينات | Non-Probability Sample |
| يقبل المتطوعين الأصحاء | نعم |
| المعايير | 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) |
النتيجة
مقاييس النتائج الأولية
1. Frequency of the different clinical manifestations at time of diagnosis and during follow-up of the hypereosinophilic syndrome (HES) [10 years]
مقاييس النتائج الثانوية
1. Frequency of the evolutionary profiles [10 years]
2. Frequency of complications depending of the type of HES [10 years]
3. Frequency of organ damage profiles before and after 18 years old. [10 years]
4. Frequency of clinical complications profiles before and after 18 years old. [10 years]
5. Frequency of HLA alleles and variants / mutations on other genes of HE/HES [10 years]
6. Serum biomarkers [10 years]
7. Difference in Membrane activation markers of HE patients (asymptomatic) versus SHE (symptomatic). [10 years]
8. Difference in Eosinophilic gene expression profiles of HE patients (asymptomatic) versus SHE (symptomatic). [10 years]
