<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/NCT03040908</url>
  </required_header>
  <id_info>
    <org_study_id>P2016/ONCO-HEMATO/HEMODREP</org_study_id>
    <nct_id>NCT03040908</nct_id>
  </id_info>
  <brief_title>New Hemolysis Parameters in Sickle Cell Disease</brief_title>
  <acronym>HEMODREP</acronym>
  <official_title>Evaluation de la capacité Physique Sous Maximale au Moyen du Test de Marche de 6 Minutes Des Enfants et Adultes Jeunes Suivis Pour drépanocytose et Nouveaux paramètres d'hémolyse : Vers Une prédiction Des Complications Vasculaires ?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen Fabiola Children's University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Queen Fabiola Children's University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The 6-minute walk (6MWT) test is used in adults and children affected by a wide range of&#xD;
      chronic diseases to evaluate their sub-maximal exercise capacity. It reflects the global&#xD;
      response of various physiological systems (respiratory, cardio-vascular, neurologic,&#xD;
      metabolic and musculosquelettic) in a situation simulating a daily life activity. In children&#xD;
      with sickle cell disease, the 6MWT is correlated with a low level of hemoglobin, a low level&#xD;
      of fetal hemoglobin and low red cell deformability. Our team previously reported that in a&#xD;
      population of children with sickle cell disease, highly treated with hydroxyurea, the sole&#xD;
      factor which was independently linked to the 6MWT was the presence of silence infarct.&#xD;
&#xD;
      As the cardio-vascular and cerebro-vascular injury in sickle cell disease are directly&#xD;
      correlated with hemolysis, the investigators aim to evaluate a) the clinical relevance of&#xD;
      endothelial and inflammation parameters and new hemolysis markers and b) if the presence of&#xD;
      silent infarct and the 6MWT are correlated with this biological markers.&#xD;
&#xD;
      This cross-sectional study will include sickle cell disease patients regularly followed for&#xD;
      more than 5 years at Hôpital Universitaire des Enfants Reine Fabiola, Centre Hospitalier&#xD;
      Universitaire (CHU)-Brugmann, Centre Hospitalier Etterbeek-Ixelles, CHU Saint-Pierre,&#xD;
      Cliniques Universitaires Saint-Luc (Bruxelles, Belgium). Inclusion criteria are: sickle cell&#xD;
      disease (SS, Sbeta°, SC, Sbeta+), age range : 6 to 25 years, signed informed consent.&#xD;
      Exclusion criteria are: transplanted patients, inability to perform the 6MWT (severe&#xD;
      cognitive disability, femoral osteonecrosis with functional impairment), hospitalization and/&#xD;
      or transfusion in the last 3 months for acute event.&#xD;
&#xD;
      Demographic data and clinical data will be retrospectively recorded. Blood test and 6MWT will&#xD;
      be performed in steady state. Studied analysis will be: coagulation factors, free hemoglobin,&#xD;
      Pro-B type natriuretic peptide (Pro-BNP), High sensitivity C reactive protein (HS-CRP),&#xD;
      Intercellular Adhesion Molecule (ICAM), Vascular Cell Adhesion Molecule (VCAM) and Selectins.&#xD;
&#xD;
      With this study, the investigators expect to validate new predictive markers for&#xD;
      cardio-vascular or cerebrovascular injury and to identify patients at high risk to develop&#xD;
      these complications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2019</start_date>
  <completion_date type="Anticipated">March 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between new biological data and clinical phenotype</measure>
    <time_frame>2 years</time_frame>
    <description>The primary outcome of this study is to validate the relationship between these new biological markers and the clinical phenotype.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between new biological data and 6-minute walk test</measure>
    <time_frame>2 years</time_frame>
    <description>The secondary outcome is to confirm the correlation between the 6-minute walk test and the presence of silent infarct and to explore the relationship between these new markers and the 6-minute walk test.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Sickle Cell Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children and young adults with Sickle Cell Disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sickle Cell Disease (HbSS, S beta°, S beta+, SC)&#xD;
&#xD;
          -  Regular follow-up from more than 5 years&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Transplanted patients&#xD;
&#xD;
          -  Hospitalisation for an acute event within 3 months&#xD;
&#xD;
          -  Acute transfusion within 3 months&#xD;
&#xD;
          -  Unable to performed 6-minute walk test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Laurence Dedeken, MD</last_name>
    <phone>+3224773469</phone>
    <email>laurence.dedeken@huderf.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bernard Wenderickx</last_name>
    <phone>+3224773654</phone>
    <email>bernard.wenderickx@huderf.be</email>
  </overall_contact_backup>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</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>Anemia, Sickle Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03040908
org study id: P2016/ONCO-HEMATO/HEMODREP
nct id: NCT03040908
lead sponsor: 
has dmc: No
The 6-minute walk (6MWT) test is used in adults and children affected by a wide range of
      chronic diseases to evaluate their sub-maximal exercise capacity. It reflects the global
      response of various physiological systems (respiratory, cardio-vascular, neurologic,
      metabolic and musculosquelettic) in a situation simulating a daily life activity. In children
      with sickle cell disease, the 6MWT is correlated with a low level of hemoglobin, a low level
      of fetal hemoglobin and low red cell deformability. Our team previously reported that in a
      population of children with sickle cell disease, highly treated with hydroxyurea, the sole
      factor which was independently linked to the 6MWT was the presence of silence infarct.

      As the cardio-vascular and cerebro-vascular injury in sickle cell disease are directly
      correlated with hemolysis, the investigators aim to evaluate a) the clinical relevance of
      endothelial and inflammation parameters and new hemolysis markers and b) if the presence of
      silent infarct and the 6MWT are correlated with this biological markers.

      This cross-sectional study will include sickle cell disease patients regularly followed for
      more than 5 years at Hôpital Universitaire des Enfants Reine Fabiola, Centre Hospitalier
      Universitaire (CHU)-Brugmann, Centre Hospitalier Etterbeek-Ixelles, CHU Saint-Pierre,
      Cliniques Universitaires Saint-Luc (Bruxelles, Belgium). Inclusion criteria are: sickle cell
      disease (SS, Sbeta°, SC, Sbeta+), age range : 6 to 25 years, signed informed consent.
      Exclusion criteria are: transplanted patients, inability to perform the 6MWT (severe
      cognitive disability, femoral osteonecrosis with functional impairment), hospitalization and/
      or transfusion in the last 3 months for acute event.

      Demographic data and clinical data will be retrospectively recorded. Blood test and 6MWT will
      be performed in steady state. Studied analysis will be: coagulation factors, free hemoglobin,
      Pro-B type natriuretic peptide (Pro-BNP), High sensitivity C reactive protein (HS-CRP),
      Intercellular Adhesion Molecule (ICAM), Vascular Cell Adhesion Molecule (VCAM) and Selectins.

      With this study, the investigators expect to validate new predictive markers for
      cardio-vascular or cerebrovascular injury and to identify patients at high risk to develop
      these complications.
observational model: Cohort
time perspective: Cross-Sectional
measure: Correlation between new biological data and clinical phenotype
time frame: 2 years
description: The primary outcome of this study is to validate the relationship between these new biological markers and the clinical phenotype.
measure: Correlation between new biological data and 6-minute walk test
time frame: 2 years
description: The secondary outcome is to confirm the correlation between the 6-minute walk test and the presence of silent infarct and to explore the relationship between these new markers and the 6-minute walk test.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 25 Years
healthy volunteers: No
last name: Laurence Dedeken, MD
phone: +3224773469
email: laurence.dedeken@huderf.be
last name: Bernard Wenderickx
phone: +3224773654
email: bernard.wenderickx@huderf.be
responsible party type: Sponsor
mesh term: Anemia, Sickle Cell
sharing ipd: Undecided