Skip to content

Iron Overload and Transient Elastography in Patients With Myelodysplastic Syndrome

Iron Overload and Transient Elastography in Patients With Myelodysplastic Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02262312
Enrollment
60
Registered
2014-10-13
Start date
2014-09-30
Completion date
Unknown
Last updated
2015-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndrome

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.

Interventions

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

Sponsors

Zealand University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Liver stiffnessTransient elastography (Fibroscan) 5 minutesLiver stiffness is measured in kilopascal (kPa)
Iron overload: FerritinBlood samples 5 minutesFerritin is measured in micrograms per liter

Secondary

MeasureTime frameDescription
Disease periodInformation regarding time of diagnosis will be obtained retrospectivelyPeriod of disease will be calculated in months
Red blood cell transfusion dependencyInformation regarding transfusion will be obtained retrospectivelyTransfusion 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 aminotransferaseBlood samples 5 minutesAlanine aminotransferase is measured in units per liter

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026