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NCT Number: NCT02262312

Iron Overload and Transient Elastography in Patients With Myelodysplastic Syndrome

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.

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Key information

Conditions

Myelodysplastic Syndrome Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic Syndromes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of hematology Roskilde hospital

Roskilde, DK-4000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transient elastography

Other

All patients will have a transient elastography performed as a measure of liver stiffness.

Other names: Fibroscan, Liver stiffness measurements

Primary outcomes

  1. Liver stiffness

    Time frame: Transient elastography (Fibroscan) 5 minutes

    Liver stiffness is measured in kilopascal (kPa)

  2. Iron overload: Ferritin

    Time frame: Blood samples 5 minutes

    Ferritin is measured in micrograms per liter

Secondary outcomes

  1. Disease period

    Time frame: Information regarding time of diagnosis will be obtained retrospectively

    Period of disease will be calculated in months

  2. Red blood cell transfusion dependency

    Time frame: 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"

  3. Liver inflammation: Alanine aminotransferase

    Time frame: Blood samples 5 minutes

    Alanine aminotransferase is measured in units per liter

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
First posted
Oct 13, 2014
Registry last updated
Jun 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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