Clinical trial NCT02262312: Iron Overload and Transient Elastography in Patients With Myelodysplastic Syndrome
Official title: Iron Overload and Transient Elastography in Patients With Myelodysplastic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelodysplastic Syndrome
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2014-10-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Liver stiffness
timeFrame: Transient elastography (Fibroscan) 5 minutes
measure: Iron overload: Ferritin
timeFrame: Blood samples 5 minutes
Secondary outcomes:
measure: Disease period
timeFrame: Information regarding time of diagnosis will be obtained retrospectively
measure: Red blood cell transfusion dependency
timeFrame: Information regarding transfusion will be obtained retrospectively
measure: Liver inflammation: Alanine aminotransferase
timeFrame: Blood samples 5 minutes
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Department of hematology Roskilde hospital
Study officials:
affiliation: Consultant at department of hematology
name: Klas Raaschou-Jensen
role: PRINCIPAL_INVESTIGATOR
References: