NCT05911620招募中不适用
Evaluation of the Severity of Hepatic Fibrosis by Magnetic Resonance Elastography in the Diagnosis of Endogenous Hypercorticism
Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2023年10月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Estimation of the severity of hepatic fibrosis by MRE (kPa).
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
Estimation of the severity of hepatic fibrosis by MRE (kPa).
时间窗: Baseline (day 0)
Estimation of the severity of hepatic fibrosis in kPa by a non-invasive elastography method : magnetic resonance elastography.
次要结局
- Evolution of transaminases (UI/L) between the diagnosis and the last visit.(1 year)
- Evaluation of the association between high blood pressure (mmHg) with the presence of Fibrosis by MRE (kPa).(Baseline (day 0))
- Evaluation of the association between overweight (kg) with the presence of Fibrosis by MRE (kPa).(Baseline (day 0))
- Evaluation of the presence of hepatic fibrosis by MRE (kPa).(Baseline (day 0))
- Evaluation of the association between osteoporosis (g/cm²) with the presence of Fibrosis by MRE (kPa).(Baseline (day 0))
- Evolution of Bilirubin (mg/L) between the diagnosis and the last visit.(1 year)
- Evolution of platelets (platelets/mm3) between the diagnosis and the last visit.(1 year)
- Evolution of Albumin (g/L) between the diagnosis and the last visit.(1 year)
- Evaluation of the association between hyperglycemia (blood glucose by g/L) with the presence of Fibrosis by MRE (kPa).(Baseline (day 0))
- Evolution of GGT (gamma-glutamyl transferase) (UI/L) between the diagnosis and the last visit.(1 year)
- Evolution of ALP (Alkaline Phosphatases) (UI/L) between the diagnosis and the last visit(1 year)
- Evolution of ferritin (ng/mL) between the diagnosis and the last visit.(1 year)
研究者
SCHEYER Nicolas
Principal Investigator
Central Hospital, Nancy, France
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Effects of Hepatic Fibrosis on Hepatic Steatosis Using the Ultrasound Attenuation Imaging in Chronic Hepatitis BHepatic SteatosisChronic Hepatitis bHepatic FibrosisNCT05871749So Yeon Kim120
已完成
不适用
Prediction of Hepatic Fibrosis in Patients With Chronic Hepatitis C by Biochemical and Duplex Doppler IndicesChronic Hepatitis CCirrhosisHepatic FibrosisNCT00466336National Taiwan University Hospital503
已完成
不适用
on-invasive measurement of hepatic fibrosis in children with cystic fibrosisliver fibrosis10018012NL-OMON31157Erasmus MC, Universitair Medisch Centrum Rotterdam100
尚未招募
不适用
on-invasive measurement of hepatic fibrosis in children with cystic fibrosisliver fibrosis10018012NL-OMON31919Erasmus MC, Universitair Medisch Centrum Rotterdam100
招募中
不适用
NAC- NAFLD And CushingFatty Liver DiseaseCushing SyndromeNCT05881005University Hospital, Angers100