<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/NCT01712542</url>
  </required_header>
  <id_info>
    <org_study_id>JohannWGUH_Curcumin-01</org_study_id>
    <nct_id>NCT01712542</nct_id>
  </id_info>
  <brief_title>Curcumin Bioavailability in Glioblastoma Patients</brief_title>
  <official_title>Measurement of Intratumoral Concentration of the Nontoxic Natural Compound Curcumin in Glioblastoma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johann Wolfgang Goethe University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johann Wolfgang Goethe University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Measuring the bioavailability of orally administered curcumin in the tumors of glioblastoma&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Concentration of Curcumin in Glioblastoma</measure>
    <time_frame>At Tumor resection</time_frame>
    <description>At the time of surgery</description>
  </primary_outcome>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Patient Harboring Glioblastoma That Will Undergo Surgery</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tumor tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients harboring Glioblastoma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients harboring Glioblastoma&#xD;
&#xD;
          -  Patient will undergo surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI &gt; 30&#xD;
&#xD;
          -  Liver and Kidney Function so compromised that medication is prescribed&#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>Stephan Duetzmann</last_name>
    <role>Principal Investigator</role>
    <affiliation>Goethe University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Neurosurgery, Johann Wolfgang Goethe-University</name>
      <address>
        <city>Frankfurt</city>
        <state>Hessen</state>
        <zip>60528</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Senft C, Polacin M, Priester M, Seifert V, Kogel D, Weissenberger J. The nontoxic natural compound Curcumin exerts anti-proliferative, anti-migratory, and anti-invasive properties against malignant gliomas. BMC Cancer. 2010 Sep 14;10:491. doi: 10.1186/1471-2407-10-491.</citation>
    <PMID>20840775</PMID>
  </reference>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>October 20, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>June 1, 2013</last_update_submitted>
  <last_update_submitted_qc>June 1, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 4, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johann Wolfgang Goethe University Hospital</investigator_affiliation>
    <investigator_full_name>Stephan Dützmann</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioblastoma</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/NCT01712542
org study id: JohannWGUH_Curcumin-01
nct id: NCT01712542
lead sponsor: 
has dmc: No
Measuring the bioavailability of orally administered curcumin in the tumors of glioblastoma
      patients.
observational model: Case-Only
time perspective: Prospective
measure: Concentration of Curcumin in Glioblastoma
time frame: At Tumor resection
description: At the time of surgery
Tumor tissue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephan Duetzmann
role: Principal Investigator
affiliation: Goethe University
facility: 
country: Germany
citation: Senft C, Polacin M, Priester M, Seifert V, Kogel D, Weissenberger J. The nontoxic natural compound Curcumin exerts anti-proliferative, anti-migratory, and anti-invasive properties against malignant gliomas. BMC Cancer. 2010 Sep 14;10:491. doi: 10.1186/1471-2407-10-491.
PMID: 20840775
responsible party type: Principal Investigator
investigator affiliation: Johann Wolfgang Goethe University Hospital
investigator full name: Stephan Dützmann
investigator title: M.D.
mesh term: Glioblastoma