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/NCT06033183</url>
    </required_header>
    <id_info>
      <org_study_id>FOCUSO</org_study_id>
      <nct_id>NCT06033183</nct_id>
    </id_info>
    <brief_title>Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology</brief_title>
    <acronym>FOCUSO</acronym>
    <official_title>Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Neolys</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Centre Francois Baclesse</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Centre Hospitalier Universitaire de Caen</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Neolys</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>
        Analysis of the individual radiosensitivity in pediatric oncology&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2027</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>Screening</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Prospectively validate the discriminating capacities of the RadioDtect© individual radiosensitivity blood test on the occurrence of early radio-induced toxicities.</measure>
      <time_frame>24 months</time_frame>
      <description>The validation will be based on ATM protein quantification assay to predict acute toxicities</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Prospectively validate the discriminating capacities of the RadioDtect© individual radiosensitivity blood test on the occurrence of early radio-induced toxicities.</measure>
      <time_frame>24 months</time_frame>
      <description>evaluation of acute toxicities of grade ≥ 2 to 3 months according to NCI-CTCAE v4.03 criteria</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Prospectively validate the discriminating capacities of the RadioDtect individual radiosensitivity blood test protein assay according on the occurrence of late radiation-induced toxicity at 12 months</measure>
      <time_frame>12 months</time_frame>
      <description>The validation will be based on ATM protein quantification assay to predict late toxicities</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prospectively validate the discriminating capacities of the RadioDtect individual radiosensitivity blood test protein assay according on the occurrence of late radiation-induced toxicity at 12 months</measure>
      <time_frame>12 months</time_frame>
      <description>evaluation of late toxicities of grade ≥ 2, according to NCI-CTCAE v4.03 criteria</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Radiosensitivity</condition>
    <condition>Pediatric Cancer</condition>
    <condition>Radiation Toxicity</condition>
    <arm_group>
      <arm_group_label>Radiosensitivity</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients who agree to participate in this research study will have blood sample collected to perform the RadioDtect test</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Blood sample</intervention_name>
      <description>Blood sample collection : 2 X 5 ml</description>
      <arm_group_label>Radiosensitivity</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Minor patient treated for a brain tumor, Ewing tumor, malignant mesenchymal tumor,&#xD;
               neuroblastoma, nephroblastoma, Hodgkin's lymphoma treated with radiotherapy (+/-&#xD;
               chemotherapy) for curative purposes.&#xD;
  &#xD;
            -  Children or adolescents &gt; 3 years old and &lt; 18 years old&#xD;
  &#xD;
            -  Patient with an indication for radiotherapy as part of the primary tumor local control&#xD;
               strategy&#xD;
  &#xD;
            -  Theoretical indication for radiotherapy in standard fractionation (1.8 Gy to 2.2 Gy /&#xD;
               fraction: 5 fr/week) whatever the technique and the particle used&#xD;
  &#xD;
            -  Patient affiliated with a social security scheme&#xD;
  &#xD;
            -  Patient and/or parents or holders of parental authority having dated and signed an&#xD;
               informed consent&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Patients with contraindications to blood sampling&#xD;
  &#xD;
            -  Patients with contraindications to radiotherapy&#xD;
  &#xD;
            -  Palliative radiotherapy&#xD;
  &#xD;
            -  Patient with previous RT treatment in the same area (re-irradiation)&#xD;
  &#xD;
            -  Patient with an indication of hypofractionated RT&#xD;
  &#xD;
            -  Patient follow-up not possible&#xD;
  &#xD;
            -  Persons deprived of liberty or under guardianship (including curatorship)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Sandrine PEREIRA, PhD</last_name>
      <phone>0643957510</phone>
      <email>spereira@neolys-diagnostics.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jennifer RUOS</last_name>
      <email>jruos@fondation-force.fr</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- 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/NCT06033183
  org study id: FOCUSO
  nct id: NCT06033183
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Analysis of the individual radiosensitivity in pediatric oncology
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Screening
  masking: None (Open Label)
  measure: Prospectively validate the discriminating capacities of the RadioDtect© individual radiosensitivity blood test on the occurrence of early radio-induced toxicities.
  time frame: 24 months
  description: The validation will be based on ATM protein quantification assay to predict acute toxicities
  measure: Prospectively validate the discriminating capacities of the RadioDtect© individual radiosensitivity blood test on the occurrence of early radio-induced toxicities.
  time frame: 24 months
  description: evaluation of acute toxicities of grade ≥ 2 to 3 months according to NCI-CTCAE v4.03 criteria
  measure: Prospectively validate the discriminating capacities of the RadioDtect individual radiosensitivity blood test protein assay according on the occurrence of late radiation-induced toxicity at 12 months
  time frame: 12 months
  description: The validation will be based on ATM protein quantification assay to predict late toxicities
  measure: Prospectively validate the discriminating capacities of the RadioDtect individual radiosensitivity blood test protein assay according on the occurrence of late radiation-induced toxicity at 12 months
  time frame: 12 months
  description: evaluation of late toxicities of grade ≥ 2, according to NCI-CTCAE v4.03 criteria
  arm group label: Radiosensitivity
  arm group type: Experimental
  description: Patients who agree to participate in this research study will have blood sample collected to perform the RadioDtect test
  intervention type: Biological
  intervention name: Blood sample
  description: Blood sample collection : 2 X 5 ml
  arm group label: Radiosensitivity
  criteria: 
  gender: All
  minimum age: 3 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Sandrine PEREIRA, PhD
  phone: 0643957510
  email: spereira@neolys-diagnostics.fr
  last name: Jennifer RUOS
  email: jruos@fondation-force.fr
  responsible party type: Sponsor