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/NCT05988970</url>
    </required_header>
    <id_info>
      <org_study_id>23 POUM 02</org_study_id>
      <nct_id>NCT05988970</nct_id>
    </id_info>
    <brief_title>Impact of Circadian Rhythm on the Spread of Circulating Tumor Cells in Lung Cancer Patients</brief_title>
    <acronym>SLEEP_CTC</acronym>
    <official_title>Impact of Circadian Rhythm on the Spread of Circulating Tumor Cells in Lung Cancer Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institut Claudius Regaud</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Institut Claudius Regaud</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 is a prospective pilot study designed to demonstrate the impact of circadian rhythm on&#xD;
        the spread of Circulating Tumor Cells (CTCs) in patients with Non- Small Cell Lung Cancer -&#xD;
        NSCLC.&#xD;
  &#xD;
        27 patients will be included in the study and will be followed for 12 months.&#xD;
  &#xD;
        For each included patient, blood samples will be collected before the anticancer treatment&#xD;
        initiation.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2024</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Presence of CTCs detected with the CellSearch technique.</measure>
      <time_frame>12 months after the end of inclusions</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Quantification of CTCs by the CellSearch technique and expressed in number of cells / millilitre of blood.</measure>
      <time_frame>12 months after the end of inclusions</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quantification of CTCs by the ParSortix technique and expressed in number of cells / millilitre of blood.</measure>
      <time_frame>12 months after the end of inclusions</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective response defined as complete or partial response.</measure>
      <time_frame>12 months after the end of inclusions</time_frame>
      <description>Response will be assessed according to the clinician's judgment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS) defined as the time between the date of inclusion and the date of first progression or death.</measure>
      <time_frame>12 months after the end of inclusions</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">27</enrollment>
    <condition>Lung Cancer</condition>
    <arm_group>
      <arm_group_label>Patients with Non- Small Cell Lung Cancer - NSCLC</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Blood samples will be collected at two times before the treatment initiation:</intervention_name>
      <description>at 4:00 a.m.&#xD;
  at 10:00 a.m.&#xD;
  Patients will then be followed for data collection for a period of 12 months after inclusion or until disease progression (if applicable).</description>
      <arm_group_label>Patients with Non- Small Cell Lung Cancer - NSCLC</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patient with histologically confirmed advanced NSCLC (inoperable stage 3 or 4)&#xD;
  &#xD;
            2. Patient aged ≥ 18 years&#xD;
  &#xD;
            3. Life expectancy &gt; 3 months&#xD;
  &#xD;
            4. Patient naïve to treatment for NSCLC&#xD;
  &#xD;
            5. Patient hospitalized at least one night for initiation of specific treatment&#xD;
               (chemotherapy, radiotherapy, surgery, other...)&#xD;
  &#xD;
            6. Patient with no other active cancer. Cancer history accepted if more than 3 years old&#xD;
               and considered cured.&#xD;
  &#xD;
            7. Patient affiliated to a Social Security scheme in France.&#xD;
  &#xD;
            8. Patient having signed informed consent prior to inclusion in the study and prior to&#xD;
               any specific study procedure.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Small-cell cancer or cancer with a majority small-cell contingent&#xD;
  &#xD;
            2. Patient previously treated for NSCLC&#xD;
  &#xD;
            3. Outpatient&#xD;
  &#xD;
            4. Patient with active pathology such as sepsis or uncontrolled inflammatory syndrome&#xD;
  &#xD;
            5. Any pathology contraindicating the sample collection procedures required by the study.&#xD;
  &#xD;
            6. Pregnant or breast-feeding women.&#xD;
  &#xD;
            7. Any psychological, family, geographical or sociological condition that makes it&#xD;
               impossible to comply with the medical follow-up and/or procedures stipulated in the&#xD;
               study protocol.&#xD;
  &#xD;
            8. Patients deprived of their liberty or under legal protection (guardianship, legal&#xD;
               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_contact>
      <last_name>Carlos GOMEZ ROCA</last_name>
      <phone>05 31 15 51 08</phone>
      <email>gomez-roca.carlos@iuct-oncopole.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hôpital Larrey</name>
        <address>
          <city>Toulouse</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Julien MAZIERES</last_name>
        <phone>05 67 77 14 86</phone>
        <email>mazieres.j@chu-toulouse.fr</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Institut Universitaire du Cancer de Toulouse - Oncopole</name>
        <address>
          <city>Toulouse</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Carlos GOMEZ ROCA</last_name>
        <phone>05 31 15 51 08</phone>
        <email>gomez-roca.carlos@iuct-oncopole.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Circadian rhythm</keyword>
    <keyword>Circulating tumor cells</keyword>
    <keyword>CTC</keyword>
    <keyword>CellSearch</keyword>
    <keyword>ParSortix</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Neoplasms</mesh_term>
      <mesh_term>Neoplastic Cells, Circulating</mesh_term>
    </condition_browse>
    <!-- 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/NCT05988970
  org study id: 23 POUM 02
  nct id: NCT05988970
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a prospective pilot study designed to demonstrate the impact of circadian rhythm on
        the spread of Circulating Tumor Cells (CTCs) in patients with Non- Small Cell Lung Cancer -
        NSCLC.
  
        27 patients will be included in the study and will be followed for 12 months.
  
        For each included patient, blood samples will be collected before the anticancer treatment
        initiation.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Presence of CTCs detected with the CellSearch technique.
  time frame: 12 months after the end of inclusions
  measure: Quantification of CTCs by the CellSearch technique and expressed in number of cells / millilitre of blood.
  time frame: 12 months after the end of inclusions
  measure: Quantification of CTCs by the ParSortix technique and expressed in number of cells / millilitre of blood.
  time frame: 12 months after the end of inclusions
  measure: Objective response defined as complete or partial response.
  time frame: 12 months after the end of inclusions
  description: Response will be assessed according to the clinician's judgment.
  measure: Progression-free survival (PFS) defined as the time between the date of inclusion and the date of first progression or death.
  time frame: 12 months after the end of inclusions
  arm group label: Patients with Non- Small Cell Lung Cancer - NSCLC
  arm group type: Other
  intervention type: Other
  intervention name: Blood samples will be collected at two times before the treatment initiation:
  description: at 4:00 a.m.
  at 10:00 a.m.
  Patients will then be followed for data collection for a period of 12 months after inclusion or until disease progression (if applicable).
  arm group label: Patients with Non- Small Cell Lung Cancer - NSCLC
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Carlos GOMEZ ROCA
  phone: 05 31 15 51 08
  email: gomez-roca.carlos@iuct-oncopole.fr
  facility: 
  contact: 
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Lung Neoplasms
  mesh term: Neoplastic Cells, Circulating