<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/NCT04461002</url>
  </required_header>
  <id_info>
    <org_study_id>RadioGLioSign</org_study_id>
    <nct_id>NCT04461002</nct_id>
  </id_info>
  <brief_title>Evaluation of the Correlation Between Molecular Phenotype and Radiological Signature (by PET-scanner and MRI) of Incident WHO II and III Grade Gliomas.</brief_title>
  <official_title>Evaluation of the Correlation Between Molecular Phenotype and Radiological Signature (by PET-scanner and MRI) of WHO II and III Grade Incident Gliomas.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GCS Ramsay Santé pour l'Enseignement et la Recherche</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GCS Ramsay Santé pour l'Enseignement et la Recherche</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>
      From the medical records of a series of patients operated on for incident grade II and III&#xD;
      glioma, the primary objective is to evaluate the correlation between the molecular profile of&#xD;
      tumours and preoperative imaging data (by FDG and FDOPA PET-scan and multimodal MRI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A retrospective monocentre study of medical data (clinical, histological, molecular and&#xD;
      imaging) contained in the medical records of patients operated on for Grade II or III&#xD;
      incident glioma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">September 30, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Primary outcome</measure>
    <time_frame>4 years</time_frame>
    <description>Evaluate the correlation between tumour molecular profile and preoperative imaging data (FDG and FDOPA PET-scan and multimodal MRI).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Molecular profile</measure>
    <time_frame>4years</time_frame>
    <description>Evaluate the overall survival and progression-free survival of patients based on the molecular profile of gliomas.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Imaging data</measure>
    <time_frame>4 years</time_frame>
    <description>To evaluate the overall survival and progression-free survival of patients based on imaging data (PET-scan and MRI) of gliomas.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">22</enrollment>
  <condition>Glioma</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
    <description>Retrospective cohort</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Retrospective analysis</intervention_name>
    <description>Evaluate the correlation between tumour molecular profile and preoperative imaging data (FDG and FDOPA PET-scan and multimodal MRI).</description>
    <arm_group_label>Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population represents the totality of patients with a glioma surgery in the&#xD;
        centre between February 2015 and May 2019, with a complete and usable medical file.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject 18 years of age or older, having been informed of the research&#xD;
&#xD;
          -  Subject operated on with an incident glioma of grade II or III, histologically&#xD;
             confirmed (WHO 2016 classification)&#xD;
&#xD;
          -  Subject for which all preoperative imaging data is available (MRI, FDG and FDOPA&#xD;
             PET-scan)&#xD;
&#xD;
          -  Subject for which molecular data of the lesion are available&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject having signified his opposition to the use of his medical data&#xD;
&#xD;
          -  Subject under safeguard of justice, guardianship or trusteeship&#xD;
&#xD;
          -  Subject with incomplete or missing part of the molecular and/or imaging data&#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>Philippe METELLUS, MD PD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Privé Clairval</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Privé Clairval</name>
      <address>
        <city>Marseille</city>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>August 16, 2021</last_update_submitted>
  <last_update_submitted_qc>August 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2021</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>Glioma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04461002
org study id: RadioGLioSign
nct id: NCT04461002
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
From the medical records of a series of patients operated on for incident grade II and III
      glioma, the primary objective is to evaluate the correlation between the molecular profile of
      tumours and preoperative imaging data (by FDG and FDOPA PET-scan and multimodal MRI).
A retrospective monocentre study of medical data (clinical, histological, molecular and
      imaging) contained in the medical records of patients operated on for Grade II or III
      incident glioma.
observational model: Case-Only
time perspective: Retrospective
measure: Primary outcome
time frame: 4 years
description: Evaluate the correlation between tumour molecular profile and preoperative imaging data (FDG and FDOPA PET-scan and multimodal MRI).
measure: Molecular profile
time frame: 4years
description: Evaluate the overall survival and progression-free survival of patients based on the molecular profile of gliomas.
measure: Imaging data
time frame: 4 years
description: To evaluate the overall survival and progression-free survival of patients based on imaging data (PET-scan and MRI) of gliomas.
arm group label: Cohort
description: Retrospective cohort
intervention type: Other
intervention name: Retrospective analysis
description: Evaluate the correlation between tumour molecular profile and preoperative imaging data (FDG and FDOPA PET-scan and multimodal MRI).
arm group label: Cohort
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philippe METELLUS, MD PD
role: Principal Investigator
affiliation: Hôpital Privé Clairval
facility: 
country: France
responsible party type: Sponsor
mesh term: Glioma
sharing ipd: No