Iron Overload and Transient Elastography in Patients With Myelodysplastic Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Myelodysplastic Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with myelodysplastic syndrome

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

Transient elastography

Intervention Type OTHER

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

Interventions

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Transient elastography

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

Intervention Type OTHER

Other Intervention Names

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Fibroscan Liver stiffness measurements

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No