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Идёт набор NCT05911620

Evaluation of the Severity of Hepatic Fibrosis by Magnetic Resonance Elastography in the Diagnosis of Endogenous Hypercorticism

Без фазы С лечением Cushing Syndrome Metabolic 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: Magnetic resonance elastography (MRE).
Кому может быть актуально
Состояния в реестре: Cushing Syndrome, Metabolic Syndrome. Базовые параметры: от 18 лет · 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The main hypothesis of the HEPACORT study is that upon diagnosis of endogenous Cushing's syndrome, significant liver fibrosis may be present, particularly in the most severe forms of Cushing's syndrome. the HEPACORT study is the first exploratory study to assess the severity of liver fibrosis in patients with Cushing's syndrome or suspected of presenting by Magnetic Resonance Elastography (MRE).

Вмешательства

  • Устройство Magnetic resonance elastography (MRE)
    Magnetic Resonance Imaging (MRI) imaging with low-frequency vibrations to create a visual map (elastogram) that shows stiffness of body tissues

Первичные конечные точки

  • Estimation of the severity of hepatic fibrosis by MRE (kPa). [Срок оценки: Baseline (day 0)]
Вторичные конечные точки (12)
  • Evaluation of the presence of hepatic fibrosis by MRE (kPa). [Срок оценки: Baseline (day 0)]
  • Evaluation of the association between hyperglycemia (blood glucose by g/L) with the presence of Fibrosis by MRE (kPa). [Срок оценки: Baseline (day 0)]
  • Evaluation of the association between high blood pressure (mmHg) with the presence of Fibrosis by MRE (kPa). [Срок оценки: Baseline (day 0)]
  • Evaluation of the association between overweight (kg) with the presence of Fibrosis by MRE (kPa). [Срок оценки: Baseline (day 0)]
  • Evaluation of the association between osteoporosis (g/cm²) with the presence of Fibrosis by MRE (kPa). [Срок оценки: Baseline (day 0)]
  • Evolution of transaminases (UI/L) between the diagnosis and the last visit. [Срок оценки: 1 year]
  • Evolution of GGT (gamma-glutamyl transferase) (UI/L) between the diagnosis and the last visit. [Срок оценки: 1 year]
  • Evolution of ALP (Alkaline Phosphatases) (UI/L) between the diagnosis and the last visit [Срок оценки: 1 year]
  • Evolution of Bilirubin (mg/L) between the diagnosis and the last visit. [Срок оценки: 1 year]
  • Evolution of Albumin (g/L) between the diagnosis and the last visit. [Срок оценки: 1 year]
  • Evolution of platelets (platelets/mm3) between the diagnosis and the last visit. [Срок оценки: 1 year]
  • Evolution of ferritin (ng/mL) between the diagnosis and the last visit. [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • age ≥ 18 years old;
  • Person affiliated to a social security scheme or beneficiary of such a scheme;
  • Person having received complete information on the organization of the research and having signed informed consent;
  • Person having carried out a preliminary clinical examination adapted to the research.
  • Patients with Cushing's syndrome (for the Cushing's Syndrome group)
  • Patients with possible Cushing's syndrome (for the suspected Cushing's Syndrome group) defined as response to the dexamethasone supression test with 1 mg of Dexamethasone, with a plasma cortisol assay at 8 am between 18 and 50 µg/L carried out in the 3 months preceding ;
  • Patients with metabolic syndrome (for the metabolic syndrome group)

Критерии исключения

  • Person having taken corticosteroid therapy for more than 3 months during the 2 years preceding inclusion;
  • Person having received corticosteroid therapy of shorter duration with discontinuation less than one month before inclusion;
  • Person having taken anticortisolic treatment for more than 3 months during the 2 years preceding inclusion;
  • Person with chronic liver disease;
  • Person with alcohol misuse, defined by a weekly consumption of more than 10 standard units;
  • Person with a morphotype that does not allow an MRI examination to be performed;
  • Woman of childbearing age who does not have an effective means of contraception;
  • Contraindication to performing an MRI examination.
  • Person referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the French Public Health Code.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Франция · 1 центр
  • CHRU Nancy — Nancy

Идентификаторы

NCT: NCT05911620 · 2022-A01786-37

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗