Iron Overload and Transient Elastography in Patients With Myelodysplastic Syndrome

Completed

• Conditions: Myelodysplastic Syndrome
• Interventions: Other: Transient elastography

• Registration Number: NCT02262312
• Lead Sponsor: Zealand University Hospital

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-18
• Study First Submitted QC: 2014-10-10
• Study First Posted: 2014-10-13
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Last Update Submitted: 2015-06-08
• Last Update Posted: 2015-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with myelodysplastic syndrome	Transient elastography	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

Primary Outcome Measures

Name	Time	Method
Liver stiffness	Transient elastography (Fibroscan) 5 minutes	Liver stiffness is measured in kilopascal (kPa)
Iron overload: Ferritin	Blood samples 5 minutes	Ferritin is measured in micrograms per liter

Secondary Outcome Measures

Name	Time	Method
Disease period	Information regarding time of diagnosis will be obtained retrospectively	Period of disease will be calculated in months
Red blood cell transfusion dependency	Information regarding transfusion will be obtained retrospectively	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"
Liver inflammation: Alanine aminotransferase	Blood samples 5 minutes	Alanine aminotransferase is measured in units per liter

Trial Locations

Locations (1)

Department of hematology Roskilde hospital; 🇩🇰 Roskilde, Denmark