<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/NCT02258035</url>
  </required_header>
  <id_info>
    <org_study_id>s57027</org_study_id>
    <nct_id>NCT02258035</nct_id>
  </id_info>
  <brief_title>Isolation of Vitamin D Binding Protein Isoforms From Human Volunteers</brief_title>
  <official_title>Isolation of Genotype-specific Isoforms of Human Vitamin D-binding Protein (DBP/Gc)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to isolate genotype-specific DBP/Gc from homozygous human&#xD;
      volunteers and use these purified proteins to cross-validate existing or novel assays for&#xD;
      this serum protein and to evaluate the binding characteristics of these variants of DBP/Gc&#xD;
      for different vitamin D metabolites.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Vitamin D binding protein binding characteristics (affinity constant)</measure>
    <time_frame>single blood draw at time of consultation, an expected average 4 years after curative treatment for breast cancer</time_frame>
    <description>In vitro characterization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation coefficient (r) of different DBP assays</measure>
    <time_frame>single blood draw at time of consultation, an expected average 4 years after curative treatment for breast cancer</time_frame>
    <description>In vitro characterization</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>DBP/Gc1f-1f genotype</arm_group_label>
    <description>Human volunteers homozygous for the 1f-1f (fast) genotype of DBP.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DBP/Gc1s-1s genotype</arm_group_label>
    <description>Human volunteers homozygous for the 1s-1s (slow) genotype of DBP.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DBP/Gc 2-2 genotype</arm_group_label>
    <description>Human volunteers homozygous for the 2-2 genotype of DBP.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood draw</intervention_name>
    <description>Sampling of 100-150 ml of blood</description>
    <arm_group_label>DBP/Gc 2-2 genotype</arm_group_label>
    <arm_group_label>DBP/Gc1f-1f genotype</arm_group_label>
    <arm_group_label>DBP/Gc1s-1s genotype</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum will be derived from 100-150 ml of blood and used for protein purification&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with known genotype of DBP/Gc, as identified in the clinical database of the&#xD;
        Multidisciplinary Breast Centre, University Hospitals Leuven, and free of breast cancer&#xD;
        recurrence at the time of blood sampling.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Generally healthy adults (≥ 18 years), non pregnant, with known DBP/Gc genotype&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide written informed consent&#xD;
&#xD;
          -  No children or pregnant women&#xD;
&#xD;
          -  Persons with known abnormal serum proteins&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dirk Vanderschueren, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Leuven</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Roger Bouillon, MD PhD</last_name>
    <role>Study Chair</role>
    <affiliation>UZ Leuven</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hans Wildiers, MD PhD</last_name>
    <role>Study Chair</role>
    <affiliation>UZ Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Hatse S, Lambrechts D, Verstuyf A, Smeets A, Brouwers B, Vandorpe T, Brouckaert O, Peuteman G, Laenen A, Verlinden L, Kriebitzsch C, Dieudonne AS, Paridaens R, Neven P, Christiaens MR, Bouillon R, Wildiers H. Vitamin D status at breast cancer diagnosis: correlation with tumor characteristics, disease outcome, and genetic determinants of vitamin D insufficiency. Carcinogenesis. 2012 Jul;33(7):1319-26. doi: 10.1093/carcin/bgs187. Epub 2012 May 23.</citation>
    <PMID>22623648</PMID>
  </reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>May 22, 2018</last_update_submitted>
  <last_update_submitted_qc>May 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vitamin D binding protein (DBP)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D Deficiency</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/NCT02258035
org study id: s57027
nct id: NCT02258035
lead sponsor: 
has dmc: No
The purpose of this study is to isolate genotype-specific DBP/Gc from homozygous human
      volunteers and use these purified proteins to cross-validate existing or novel assays for
      this serum protein and to evaluate the binding characteristics of these variants of DBP/Gc
      for different vitamin D metabolites.
observational model: Case-Only
time perspective: Prospective
measure: Vitamin D binding protein binding characteristics (affinity constant)
time frame: single blood draw at time of consultation, an expected average 4 years after curative treatment for breast cancer
description: In vitro characterization
measure: Correlation coefficient (r) of different DBP assays
time frame: single blood draw at time of consultation, an expected average 4 years after curative treatment for breast cancer
description: In vitro characterization
arm group label: DBP/Gc1f-1f genotype
description: Human volunteers homozygous for the 1f-1f (fast) genotype of DBP.
arm group label: DBP/Gc1s-1s genotype
description: Human volunteers homozygous for the 1s-1s (slow) genotype of DBP.
arm group label: DBP/Gc 2-2 genotype
description: Human volunteers homozygous for the 2-2 genotype of DBP.
intervention type: Other
intervention name: Blood draw
description: Sampling of 100-150 ml of blood
arm group label: DBP/Gc 2-2 genotype
arm group label: DBP/Gc1f-1f genotype
arm group label: DBP/Gc1s-1s genotype
Serum will be derived from 100-150 ml of blood and used for protein purification
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dirk Vanderschueren, MD PhD
role: Principal Investigator
affiliation: UZ Leuven
last name: Roger Bouillon, MD PhD
role: Study Chair
affiliation: UZ Leuven
last name: Hans Wildiers, MD PhD
role: Study Chair
affiliation: UZ Leuven
facility: 
country: Belgium
citation: Hatse S, Lambrechts D, Verstuyf A, Smeets A, Brouwers B, Vandorpe T, Brouckaert O, Peuteman G, Laenen A, Verlinden L, Kriebitzsch C, Dieudonne AS, Paridaens R, Neven P, Christiaens MR, Bouillon R, Wildiers H. Vitamin D status at breast cancer diagnosis: correlation with tumor characteristics, disease outcome, and genetic determinants of vitamin D insufficiency. Carcinogenesis. 2012 Jul;33(7):1319-26. doi: 10.1093/carcin/bgs187. Epub 2012 May 23.
PMID: 22623648
responsible party type: Sponsor
mesh term: Vitamin D Deficiency