Iron Overload and Transient Elastography in Patients With Myelodysplastic Syndrome

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Iron Overload and Transient Elastography in Patients With Myelodysplastic Syndrome

Conditions
-----------------
Myelodysplastic Syndrome

Intervention / Treatment
-----------------
* Other: Transient elastography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with myelodysplastic syndrome<br>Patients with myelodysplastic syndrome among these include also patients with chronic myelomonocytic leukemia with myelodysplasia, patients with acute myeloid leukemia progressed from myelodysplastic syndrome and patients with myelodysplastic/myeloproliferative neoplasm, unclassifiable | Other: Transient elastography<br>* All patients will have a transient elastography performed as a measure of liver stiffness.<br>* Other names: Liver stiffness measurements;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver stiffness | Liver stiffness is measured in kilopascal (kPa) | Transient elastography (Fibroscan) 5 minutes | 
| Iron overload: Ferritin | Ferritin is measured in micrograms per liter | Blood samples 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease period | Period of disease will be calculated in months | Information regarding time of diagnosis will be obtained retrospectively | 
| Red blood cell transfusion dependency | Transfusion dependency will be defined as having at least one red blood cell transfusion every other eight weeks over a period of four months prior to the date of the fibroscan. Red blood cell dependency will be either yes or no | Information regarding transfusion will be obtained retrospectively | 
| Liver inflammation: Alanine aminotransferase | Alanine aminotransferase is measured in units per liter | Blood samples 5 minutes |