xml: <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/NCT06001281</url>
    </required_header>
    <id_info>
      <org_study_id>RCAPHM23_0011</org_study_id>
      <nct_id>NCT06001281</nct_id>
    </id_info>
    <brief_title>Predictive Value of Soluble CD146 in Glioblastoma Patients</brief_title>
    <acronym>MUCIGLIO-01</acronym>
    <official_title>Predictive Value of Soluble CD146 in Patients With Recurrent Glioblastoma Treated by Bevacizumab</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assistance Publique Hopitaux De Marseille</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assistance Publique Hopitaux De Marseille</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>
        Glioblastoma is the most common malignant primary brain tumor with poor prognosis because of&#xD;
        its diffusive and infiltrative nature. The FDA approved the use of the anti-VEGF antibody&#xD;
        bevacizumab in recurrent GBM. However, resistance to this anti-angiogenic reagent is frequent&#xD;
        and fails to enhance patients' overall survival. The investigators previously identified one&#xD;
        novel mechanism responsible for bevacizumab-resistance in CD146-positive glioblastoma&#xD;
        (Joshkon et al. Acta Neuropathol Commun, 2022).&#xD;
  &#xD;
        Now, the investigators objective is to prospectively monitor the soluble CD146 value in&#xD;
        plasma from patients treated by bevacizumab for recurrent glioblastoma.&#xD;
  &#xD;
        The investigators will collect plasma at baseline, before the first bevacizumab&#xD;
        administration, before the second administration, at the time of first MRI evaluation and at&#xD;
        progression. Plasma CD146 value will be analyzed by ELISA.&#xD;
  &#xD;
        The investigators expect to confirm the correlation between soluble CD146 value in plasma and&#xD;
        patient response to bevacizumab.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">November 2025</completion_date>
    <primary_completion_date type="Anticipated">November 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>correlation between soluble CD146 plasma value and patient response (RANO)</measure>
      <time_frame>first evaluation (2 months)</time_frame>
      <description>Soluble CD146 plasma value will be assessed using ELISA. Patient response will be evaluated by MRI and clinical response using the international RANO criteria.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">55</enrollment>
    <condition>Glioblastoma</condition>
    <arm_group>
      <arm_group_label>plasma collection</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Plasma samples will be prospectively collected at relevant time points during patient treatment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>plasma collection</intervention_name>
      <description>Plasma samples will be prospectively collected at relevant time points during patient treatment.</description>
      <arm_group_label>plasma collection</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  - Adult patients with recurrent IDHwt glioblastoma&#xD;
  &#xD;
            -  Relapse after standard first line treatment (radio-chemotherapy)&#xD;
  &#xD;
            -  Candidate for bevacizumab treatment&#xD;
  &#xD;
            -  Able to be monitored by MRI&#xD;
  &#xD;
            -  KPS ≥ 60%&#xD;
  &#xD;
            -  Written signed consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy or breast feeding&#xD;
  &#xD;
            -  Life expectancy less than 3 months&#xD;
  &#xD;
            -  Bevacizumab in first line treatment&#xD;
  &#xD;
            -  Other concomitant life-threatening disease&#xD;
  &#xD;
            -  Under legal protection&#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>Emeline Tabouret</last_name>
      <role>Principal Investigator</role>
      <affiliation>AP-HM</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Anaïs Maugard</last_name>
      <phone>0491435186</phone>
      <email>anais.maugard@ap-hm.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>DRSMR AP-HM</last_name>
      <email>promotion.interne@ap-hm.fr</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>glioblastoma</keyword>
    <keyword>CD146</keyword>
    <keyword>bevacizumab</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Glioblastoma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06001281
  org study id: RCAPHM23_0011
  nct id: NCT06001281
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Glioblastoma is the most common malignant primary brain tumor with poor prognosis because of
        its diffusive and infiltrative nature. The FDA approved the use of the anti-VEGF antibody
        bevacizumab in recurrent GBM. However, resistance to this anti-angiogenic reagent is frequent
        and fails to enhance patients' overall survival. The investigators previously identified one
        novel mechanism responsible for bevacizumab-resistance in CD146-positive glioblastoma
        (Joshkon et al. Acta Neuropathol Commun, 2022).
  
        Now, the investigators objective is to prospectively monitor the soluble CD146 value in
        plasma from patients treated by bevacizumab for recurrent glioblastoma.
  
        The investigators will collect plasma at baseline, before the first bevacizumab
        administration, before the second administration, at the time of first MRI evaluation and at
        progression. Plasma CD146 value will be analyzed by ELISA.
  
        The investigators expect to confirm the correlation between soluble CD146 value in plasma and
        patient response to bevacizumab.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: correlation between soluble CD146 plasma value and patient response (RANO)
  time frame: first evaluation (2 months)
  description: Soluble CD146 plasma value will be assessed using ELISA. Patient response will be evaluated by MRI and clinical response using the international RANO criteria.
  arm group label: plasma collection
  arm group type: Other
  description: Plasma samples will be prospectively collected at relevant time points during patient treatment.
  intervention type: Other
  intervention name: plasma collection
  description: Plasma samples will be prospectively collected at relevant time points during patient treatment.
  arm group label: plasma collection
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Emeline Tabouret
  role: Principal Investigator
  affiliation: AP-HM
  last name: Anaïs Maugard
  phone: 0491435186
  email: anais.maugard@ap-hm.fr
  last name: DRSMR AP-HM
  email: promotion.interne@ap-hm.fr
  responsible party type: Sponsor
  mesh term: Glioblastoma
  sharing ipd: No