<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/NCT03288012</url>
  </required_header>
  <id_info>
    <org_study_id>NL60834.018.17</org_study_id>
    <nct_id>NCT03288012</nct_id>
  </id_info>
  <brief_title>Sickle Cell Disease: Targeting Alloantibody Formation Reduction; Risk Factors, and Genetics</brief_title>
  <acronym>STARRING</acronym>
  <official_title>Sickle Cell Disease: Targeting Alloantibody Formation Reduction; Risk Factors, and Genetics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanquin Research &amp; Blood Bank Divisions</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>HagaZiekenhuis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sanquin Research &amp; Blood Bank Divisions</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The focus of the study is the pathophysiological mechanism of allo-antibody formation after&#xD;
      red blood cell transfusion in sickle cell disease patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objectives of this study are to study the role of the innate and adaptive immune&#xD;
      response in allo-antibody formation and furthermore to identify the genetic and time&#xD;
      dependent clinical risk factors on alloimmunization in SCD patients.&#xD;
&#xD;
      Subjects without allo-antibodies, receiving a red blood cell transfusion, will be included in&#xD;
      this study. At 5 time points blood will be drawn from these subjects. (T0: Before&#xD;
      transfusion, T1: 1 day after transfusion, T2: 1 week after transfusion, T3: 4 weeks after&#xD;
      transfusion, T4: 6 months after transfusion).&#xD;
&#xD;
      At each time point specific markers of the immune system will be measured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 20, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The innate and adaptive immune response of patients with sickle cell disease that form allo-antibodies following erythrocyte transfusion, compared to patients that do not form alloantibodies following erythrocyte transfusion</measure>
    <time_frame>6 months</time_frame>
    <description>Multiple activating and regulatory markers of the innate and adaptive immune system will be measured at the indicated time points and compared between cases and controls</description>
  </primary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Alloimmunization</condition>
  <condition>Sickle Cell Disease</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples for DNA analysis and analysis of immune system components involved in&#xD;
      alloimmune reactions following erythrocyte transfusion&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Sickle cell disease population receiving care in the participating hospitals&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sickle cell disease&#xD;
&#xD;
          -  Receiving a red blood cell transfusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous positive screen for allo-antibodies&#xD;
&#xD;
          -  &gt;25 red blood cell units in the past&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Karin Fijnvandraat, MD PhD</last_name>
    <phone>+31205123122</phone>
    <email>k.fijnvandraat@sanquin.nl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Academic Medical Center Amsterdam</name>
      <address>
        <city>Amsterdam-Zuidoost</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karin Fijnvandraat, PhD</last_name>
      <phone>+31 02 5123122</phone>
      <email>c.j.fijnvandraat@amc.nl</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>HagaZiekenhuis</name>
      <address>
        <city>Den Haag</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jean Louis Kerkhoffs, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Jean-Louis Kerkhoffs, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Radboudumc</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>S Schols, MD</last_name>
      <phone>0031243618800</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Erasmus MC</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marjon Cnossen, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Marjon Cnossen, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>July 17, 2019</last_update_submitted>
  <last_update_submitted_qc>July 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 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>
  <!-- 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/NCT03288012
org study id: NL60834.018.17
nct id: NCT03288012
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The focus of the study is the pathophysiological mechanism of allo-antibody formation after
      red blood cell transfusion in sickle cell disease patients.
The main objectives of this study are to study the role of the innate and adaptive immune
      response in allo-antibody formation and furthermore to identify the genetic and time
      dependent clinical risk factors on alloimmunization in SCD patients.

      Subjects without allo-antibodies, receiving a red blood cell transfusion, will be included in
      this study. At 5 time points blood will be drawn from these subjects. (T0: Before
      transfusion, T1: 1 day after transfusion, T2: 1 week after transfusion, T3: 4 weeks after
      transfusion, T4: 6 months after transfusion).

      At each time point specific markers of the immune system will be measured.
observational model: Cohort
time perspective: Prospective
measure: The innate and adaptive immune response of patients with sickle cell disease that form allo-antibodies following erythrocyte transfusion, compared to patients that do not form alloantibodies following erythrocyte transfusion
time frame: 6 months
description: Multiple activating and regulatory markers of the innate and adaptive immune system will be measured at the indicated time points and compared between cases and controls
Blood samples for DNA analysis and analysis of immune system components involved in
      alloimmune reactions following erythrocyte transfusion
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Karin Fijnvandraat, MD PhD
phone: +31205123122
email: k.fijnvandraat@sanquin.nl
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Netherlands
responsible party type: Sponsor
mesh term: Anemia, Sickle Cell