Iron Overload and Transient Elastography in Patients With Myelodysplastic Syndrome

Myelodysplastic Syndrome Clinical Trial

Official title:

Iron Overload and Transient Elastography in Patients With Myelodysplastic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02262312
• Other study ID #: SJ-402
• Status: Completed
• Phase: Phase 0
• First received: September 18, 2014
• Last updated: June 8, 2015
• Start date: September 2014

Study information

• Verified date: June 2015
• Source: Roskilde County Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Iron Overload
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Other:
• Transient elastography
All patients will have a transient elastography performed as a measure of liver stiffness.

Locations

Country	Name	City	State
Denmark	Department of hematology Roskilde hospital	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Roskilde County Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver stiffness	Liver stiffness is measured in kilopascal (kPa)	Transient elastography (Fibroscan) 5 minutes	No
Primary	Iron overload: Ferritin	Ferritin is measured in micrograms per liter	Blood samples 5 minutes	No
Secondary	Disease period	Period of disease will be calculated in months	Information regarding time of diagnosis will be obtained retrospectively	No
Secondary	Red blood cell transfusion dependency	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"	Information regarding transfusion will be obtained retrospectively	No
Secondary	Liver inflammation: Alanine aminotransferase	Alanine aminotransferase is measured in units per liter	Blood samples 5 minutes	No