Iron Overload and Transient Elastography in Patients With Myelodysplastic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Liver stiffness
研究概览
简要总结
Patients with myelodysplastic syndrome (MDS) have an ineffective hemopoiesis and often suffer from anemia. This can lead to red blood cell transfusion dependency and iron overload. Iron overload can affect the liver and lead to liver fibrosis and worst case cirrhosis. Ferritin is usually used to monitor the iron overload. In this study MDS patients will have a transient elastography performed which measures the liver's stiffness. The purpose is to investigate whether liver stiffness measurements are coherent to ferritin levels.
详细描述
Transient elastography is noninvasive and has no side effects. No liver biopsy will be performed due to serious side-effects and risks in this patientgroup.
The results of the transient elastography will be compared to the patient's ferritin levels and the numbers of months the patients have had MDS to find out if there is a correlation. Furthermore we will compare the liver stiffness measurements in the patients with higher ferritin levels to those who have lower ferritin levels. We will also compare the liver stiffness measurements in patients who are red blood cell transfusion dependent compared to those who are red blood cell transfusion independent. We will also compare liver stiffness measurements in the patients with a high alanine aminotransferase (ALAT) compared to those with normal ALAT.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Patients with a bone marrow describing myelodysplasia
- •Among these:
- •Patients with myelodysplastic syndrome (MDS)
- •Patients with acute myeloid leukemia (AML) transformed from MDS
- •Patients with chronic myelomonocytic leukemia (CMML) with dysplasia
- •Patients with myelodysplastic/myeloproliferative neoplasm, unclassifiable
排除标准
- •Body mass index (BMI) of 30 or higher than 30
- •History with other known liver diseases
- •Among these:
- •Patients with chronic viral hepatitis C infection
- •Patients with chronic viral hepatitis B infection
- •Patients with alcoholic liver cirrhosis
结局指标
主要结局
Liver stiffness
时间窗: Transient elastography (Fibroscan) 5 minutes
Liver stiffness is measured in kilopascal (kPa)
Iron overload: Ferritin
时间窗: Blood samples 5 minutes
Ferritin is measured in micrograms per liter
次要结局
- Disease period(Information regarding time of diagnosis will be obtained retrospectively)
- Red blood cell transfusion dependency(Information regarding transfusion will be obtained retrospectively)
- Liver inflammation: Alanine aminotransferase(Blood samples 5 minutes)