Iron Overload and Transient Elastography in Patients With Myelodysplastic Syndrome

Zealand University Hospital

Status: Completed

Conditions: Myelodysplastic Syndrome

Treatments: Other: Transient elastography

Study type: Observational

Funder types: Other

Identifiers

NCT02262312

SJ-402

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

Patients with myelodysplastic syndrome

Description:

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

Treatment:

Other: Transient elastography