Iron Overload and Transient Elastography in Patients With Myelodysplastic Syndrome

NCT02262312 | Completed

• 1 other identifier: SJ-402
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (2)

• Liver stiffness

  Liver stiffness is measured in kilopascal (kPa)

  Transient elastography (Fibroscan) 5 minutes

• Iron overload: Ferritin

  Ferritin is measured in micrograms per liter

  Blood samples 5 minutes

Secondary Outcomes (3)

• Disease period

  Information regarding time of diagnosis will be obtained retrospectively

• Red blood cell transfusion dependency

  Information regarding transfusion will be obtained retrospectively

• Liver inflammation: Alanine aminotransferase

  Blood samples 5 minutes

Study Arms (1)

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

Other: Transient elastography

Interventions

Transient elastography OTHER

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

Also known as: Fibroscan, Liver stiffness measurements

Patients with myelodysplastic syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Department of hematology Roskilde hospital

Roskilde, Roskilde, DK-4000, Denmark

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Klas Raaschou-Jensen

  Consultant at department of hematology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: October 13, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2015
• Last Updated: June 9, 2015

Record last verified: 2015-06

Locations

DK (1)