<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02262312</url>
  </required_header>
  <id_info>
    <org_study_id>SJ-402</org_study_id>
    <nct_id>NCT02262312</nct_id>
  </id_info>
  <brief_title>Iron Overload and Transient Elastography in Patients With Myelodysplastic Syndrome</brief_title>
  <official_title>Iron Overload and Transient Elastography in Patients With Myelodysplastic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zealand University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zealand University Hospital</source>
  <brief_summary>
    <textblock>
      Patients with myelodysplastic syndrome (MDS) have an ineffective hemopoiesis and often suffer&#xD;
      from anemia. This can lead to red blood cell transfusion dependency and iron overload. Iron&#xD;
      overload can affect the liver and lead to liver fibrosis and worst case cirrhosis. Ferritin&#xD;
      is usually used to monitor the iron overload. In this study MDS patients will have a&#xD;
      transient elastography performed which measures the liver's stiffness. The purpose is to&#xD;
      investigate whether liver stiffness measurements are coherent to ferritin levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Transient elastography is noninvasive and has no side effects. No liver biopsy will be&#xD;
      performed due to serious side-effects and risks in this patientgroup.&#xD;
&#xD;
      The results of the transient elastography will be compared to the patient's ferritin levels&#xD;
      and the numbers of months the patients have had MDS to find out if there is a correlation.&#xD;
      Furthermore we will compare the liver stiffness measurements in the patients with higher&#xD;
      ferritin levels to those who have lower ferritin levels. We will also compare the liver&#xD;
      stiffness measurements in patients who are red blood cell transfusion dependent compared to&#xD;
      those who are red blood cell transfusion independent. We will also compare liver stiffness&#xD;
      measurements in the patients with a high alanine aminotransferase (ALAT) compared to those&#xD;
      with normal ALAT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Liver stiffness</measure>
    <time_frame>Transient elastography (Fibroscan) 5 minutes</time_frame>
    <description>Liver stiffness is measured in kilopascal (kPa)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Iron overload: Ferritin</measure>
    <time_frame>Blood samples 5 minutes</time_frame>
    <description>Ferritin is measured in micrograms per liter</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease period</measure>
    <time_frame>Information regarding time of diagnosis will be obtained retrospectively</time_frame>
    <description>Period of disease will be calculated in months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Red blood cell transfusion dependency</measure>
    <time_frame>Information regarding transfusion will be obtained retrospectively</time_frame>
    <description>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 &quot;yes&quot; or &quot;no&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver inflammation: Alanine aminotransferase</measure>
    <time_frame>Blood samples 5 minutes</time_frame>
    <description>Alanine aminotransferase is measured in units per liter</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Myelodysplastic Syndrome</condition>
  <arm_group>
    <arm_group_label>Patients with myelodysplastic syndrome</arm_group_label>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Transient elastography</intervention_name>
    <description>All patients will have a transient elastography performed as a measure of liver stiffness.</description>
    <arm_group_label>Patients with myelodysplastic syndrome</arm_group_label>
    <other_name>Fibroscan</other_name>
    <other_name>Liver stiffness measurements</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with myelodysplastic syndrome among these include also patients with chronic&#xD;
        myelomonocytic leukemia with myelodysplasia, patients with acute myeloid leukemia&#xD;
        progressed from myelodysplastic syndrome and patients with&#xD;
        myelodysplastic/myeloproliferative neoplasm, unclassifiable.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a bone marrow describing myelodysplasia&#xD;
&#xD;
        Among these:&#xD;
&#xD;
          -  Patients with myelodysplastic syndrome (MDS)&#xD;
&#xD;
          -  Patients with acute myeloid leukemia (AML) transformed from MDS&#xD;
&#xD;
          -  Patients with chronic myelomonocytic leukemia (CMML) with dysplasia&#xD;
&#xD;
          -  Patients with myelodysplastic/myeloproliferative neoplasm, unclassifiable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Body mass index (BMI) of 30 or higher than 30&#xD;
&#xD;
        - History with other known liver diseases&#xD;
&#xD;
        Among these:&#xD;
&#xD;
          -  Patients with chronic viral hepatitis C infection&#xD;
&#xD;
          -  Patients with chronic viral hepatitis B infection&#xD;
&#xD;
          -  Patients with alcoholic liver cirrhosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Klas Raaschou-Jensen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Consultant at department of hematology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of hematology Roskilde hospital</name>
      <address>
        <city>Roskilde</city>
        <zip>DK-4000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>June 8, 2015</last_update_submitted>
  <last_update_submitted_qc>June 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Preleukemia</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
    <mesh_term>Iron Overload</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02262312
org study id: SJ-402
nct id: NCT02262312
lead sponsor: 
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.
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.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Liver stiffness
time frame: Transient elastography (Fibroscan) 5 minutes
description: Liver stiffness is measured in kilopascal (kPa)
measure: Iron overload: Ferritin
time frame: Blood samples 5 minutes
description: Ferritin is measured in micrograms per liter
measure: Disease period
time frame: Information regarding time of diagnosis will be obtained retrospectively
description: Period of disease will be calculated in months
measure: Red blood cell transfusion dependency
time frame: Information regarding transfusion will be obtained retrospectively
description: 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"
measure: Liver inflammation: Alanine aminotransferase
time frame: Blood samples 5 minutes
description: Alanine aminotransferase is measured in units per liter
arm group label: Patients with myelodysplastic syndrome
description: 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
intervention type: Other
intervention name: Transient elastography
description: All patients will have a transient elastography performed as a measure of liver stiffness.
arm group label: Patients with myelodysplastic syndrome
other name: Fibroscan
other name: Liver stiffness measurements
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Klas Raaschou-Jensen
role: Principal Investigator
affiliation: Consultant at department of hematology
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Preleukemia
mesh term: Myelodysplastic Syndromes
mesh term: Iron Overload
mesh term: Syndrome