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Идёт набор NCT04018118

Natural History of Hypereosinophilia and Hypereosinophilic Syndromes

— Наблюдательное Eosinophilia Hypereosinophilic Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Biological sample.
Кому может быть актуально
Состояния в реестре: Eosinophilia, Hypereosinophilic Syndrome. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

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

Обзор

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, ..)

Подробное описание

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.

Вмешательства

  • Биопрепарат Biological sample
    Additional blood samples for biobanking

Первичные конечные точки

  • Frequency of the different clinical manifestations at time of diagnosis and during follow-up of the hypereosinophilic syndrome (HES) [Срок оценки: 10 years]
Вторичные конечные точки (8)
  • Frequency of the evolutionary profiles [Срок оценки: 10 years]
  • Frequency of complications depending of the type of HES [Срок оценки: 10 years]
  • Frequency of organ damage profiles before and after 18 years old. [Срок оценки: 10 years]
  • Frequency of clinical complications profiles before and after 18 years old. [Срок оценки: 10 years]
  • Frequency of HLA alleles and variants / mutations on other genes of HE/HES [Срок оценки: 10 years]
  • Serum biomarkers [Срок оценки: 10 years]
  • Difference in Membrane activation markers of HE patients (asymptomatic) versus SHE (symptomatic). [Срок оценки: 10 years]
  • Difference in Eosinophilic gene expression profiles of HE patients (asymptomatic) versus SHE (symptomatic). [Срок оценки: 10 years]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Hôpital Roger Salengro, CHU — Lille

Публикации

  • 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, Leu PMID 39757773

Идентификаторы

NCT: NCT04018118 · 2018_36 · 2018-A02624-51

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗