<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/NCT03770468</url>
  </required_header>
  <id_info>
    <org_study_id>EORTC-1419-BTG</org_study_id>
    <nct_id>NCT03770468</nct_id>
  </id_info>
  <brief_title>Molecular Genetic, Host-derived and Clinical Determinants of Long-term Survival in Glioblastoma</brief_title>
  <official_title>Molecular Genetic, Host-derived and Clinical Determinants of Long-term Survival in Glioblastoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Organisation for Research and Treatment of Cancer - EORTC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>European Organisation for Research and Treatment of Cancer - EORTC</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pro - and retrospective multicenter clinical epidemiological study studies the molecular&#xD;
      genetic, host-derived and clinical determinants of glioblastoma patients with an overall&#xD;
      survival of more than 5 years. The different research focusses are:&#xD;
&#xD;
        -  Identification of clinical parameters and patient characteristics / host-related factors&#xD;
           in long-term survivors (Focus 1)&#xD;
&#xD;
        -  Identification of molecular tumor characteristics in long-term survivors (Focus 2)&#xD;
&#xD;
        -  Assessment of therapy-related parameters, including neuro-toxicity (Focus 3)&#xD;
&#xD;
        -  Immunological studies (Focus 4)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 5, 2015</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>1 year from last patient in</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Molecular profiling on FFPE samples</measure>
    <time_frame>1 year from last patient in</time_frame>
    <description>Profiling for cytosine-phosphate-guanosine (CpG) methylation patterns using the Illumina 850k bead array platform</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Molecular profiling on frozen samples</measure>
    <time_frame>1 year from last patient in</time_frame>
    <description>Samples will be subjected to whole exome sequencing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Molecular profiling on frozen samples</measure>
    <time_frame>1 year from last patient in</time_frame>
    <description>Samples will be subjected to messenger ribonucleic acid (mRNA) sequencing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Molecular profiling on frozen samples</measure>
    <time_frame>1 year from last patient in</time_frame>
    <description>Samples will be subjected to miRNA sequencing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Molecular profiling on frozen samples</measure>
    <time_frame>1 year from last patient in</time_frame>
    <description>Samples will be subjected to microarray-based expression profiling</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proteome profiling</measure>
    <time_frame>1 year from last patient in</time_frame>
    <description>Tumor cells will be microdissected from frozen sections and prepared for high-resolution mass spectrometry</description>
  </primary_outcome>
  <enrollment type="Actual">599</enrollment>
  <condition>Glioblastoma</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood drawl</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Glioblastoma patients with overall survival &gt; 5 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years at diagnosis&#xD;
&#xD;
          -  Histopathological diagnosis of glioblastoma (reference histology available) and&#xD;
&#xD;
          -  Survival &gt;5 years from diagnosis&#xD;
&#xD;
          -  Availability of tumor tissue from initial glioblastoma diagnosis (FFPE or&#xD;
             fresh-frozen) to validate the diagnosis centrally.&#xD;
&#xD;
          -  Signed consent form (living patients) or ethics approval for anonymous data collection&#xD;
             in case of retrospective analysis of deceased patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not applicable&#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>Michael Weller</last_name>
    <role>Principal Investigator</role>
    <affiliation>EORTC Study Coordinator</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute &amp; Harvard Medical School</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115-5450</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Wien - AKH uniklinieken</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopitaux Universitaires Bordet-Erasme</name>
      <address>
        <city>Brussel</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Lyon - Hopital neurologique Pierre Wertheimer</name>
      <address>
        <city>Bron</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Lille</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopitaux de Marseille - Hôpital de La Timone (APHM)</name>
      <address>
        <city>Marseille</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut du Cancer de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nice - Hopital Pasteur</name>
      <address>
        <city>Nice</city>
        <zip>6000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopitaux de Paris - Hopital Saint-Louis</name>
      <address>
        <city>Paris</city>
        <zip>75475</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopitaux de Paris - La Pitie Salpetriere</name>
      <address>
        <city>Paris</city>
        <zip>75651</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU d'Amiens - CHU Amiens - Hopital Sud</name>
      <address>
        <city>Salouël</city>
        <zip>80480</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Bonn</name>
      <address>
        <city>Bonn</city>
        <zip>53105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Carl Gustav Carus</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum - Essen</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ronellenfitsch Michael</name>
      <address>
        <city>Frankfurt</city>
        <zip>60528</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Freiburg</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UniversitaetsKlinikum Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern</name>
      <address>
        <city>Muenchen</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Technische Universitaet Muenchen - Klinikum Rechts Der Isar</name>
      <address>
        <city>Muenchen</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Regensburg</name>
      <address>
        <city>Regensburg</city>
        <zip>93053</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hygeia Hospital</name>
      <address>
        <city>Athens</city>
        <zip>151 23</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Di Padova - Istituto Oncologico Veneto IRCCS</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amsterdam UMC - locatie VUmc</name>
      <address>
        <city>Amsterdam</city>
        <zip>1081HV</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus MC</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 GD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois - Lausanne</name>
      <address>
        <city>Lausanne</city>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ. Spital Zurich</name>
      <address>
        <city>Zürich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Switzerland</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>November 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>September 13, 2022</last_update_submitted>
  <last_update_submitted_qc>September 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2022</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>Glioblastoma</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/NCT03770468
org study id: EORTC-1419-BTG
nct id: NCT03770468
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This pro - and retrospective multicenter clinical epidemiological study studies the molecular
      genetic, host-derived and clinical determinants of glioblastoma patients with an overall
      survival of more than 5 years. The different research focusses are:

        -  Identification of clinical parameters and patient characteristics / host-related factors
           in long-term survivors (Focus 1)

        -  Identification of molecular tumor characteristics in long-term survivors (Focus 2)

        -  Assessment of therapy-related parameters, including neuro-toxicity (Focus 3)

        -  Immunological studies (Focus 4)
observational model: Other
time perspective: Cross-Sectional
measure: Overall Survival
time frame: 1 year from last patient in
measure: Molecular profiling on FFPE samples
time frame: 1 year from last patient in
description: Profiling for cytosine-phosphate-guanosine (CpG) methylation patterns using the Illumina 850k bead array platform
measure: Molecular profiling on frozen samples
time frame: 1 year from last patient in
description: Samples will be subjected to whole exome sequencing
measure: Molecular profiling on frozen samples
time frame: 1 year from last patient in
description: Samples will be subjected to messenger ribonucleic acid (mRNA) sequencing
measure: Molecular profiling on frozen samples
time frame: 1 year from last patient in
description: Samples will be subjected to miRNA sequencing
measure: Molecular profiling on frozen samples
time frame: 1 year from last patient in
description: Samples will be subjected to microarray-based expression profiling
measure: Proteome profiling
time frame: 1 year from last patient in
description: Tumor cells will be microdissected from frozen sections and prepared for high-resolution mass spectrometry
intervention type: Procedure
intervention name: Blood drawl
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Weller
role: Principal Investigator
affiliation: EORTC Study Coordinator
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country: Austria
country: Belgium
country: France
country: Germany
country: Greece
country: Italy
country: Netherlands
country: Switzerland
country: United States
responsible party type: Sponsor
mesh term: Glioblastoma
sharing ipd: Undecided