<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/NCT03284684</url>
  </required_header>
  <id_info>
    <org_study_id>NIMAO/2016/PC-01</org_study_id>
    <nct_id>NCT03284684</nct_id>
  </id_info>
  <brief_title>Kinetics of Perioperative Circulating DNA in Cancer Surgery</brief_title>
  <acronym>Periop ctDNA</acronym>
  <official_title>Kinetics of Perioperative Circulating DNA in Cancer Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nīmes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nīmes</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>
      The aim of this study was to determine the kinetics of perioperative circulating DNA in three&#xD;
      types of cancer. This first step will enable further studies comparing the potential impact&#xD;
      of certain techniques or anesthetic products on cancer surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 22, 2018</start_date>
  <completion_date type="Actual">November 11, 2018</completion_date>
  <primary_completion_date type="Actual">November 11, 2018</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in concentration of total mutant circulating DNA</measure>
    <time_frame>Nine timepoints between Day-1 to Day 3</time_frame>
    <description>ng/mL in plasma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in proportion of mutant circulating DNA</measure>
    <time_frame>Nine timepoints between Day-1 to Day 3</time_frame>
    <description>ng/mL in plasma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in integrity index of circulating DNA for ACTB gene</measure>
    <time_frame>Nine timepoints between Day-1 to Day 3</time_frame>
    <description>concentration of long ACTB ctDNA fragments/concentration of short ACTB ctDNA fragments</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in integrity index of circulating DNA for KRAS gene</measure>
    <time_frame>Nine timepoints between Day-1 to Day 3</time_frame>
    <description>concentration of long KRAS ctDNA fragments/concentration of short KRAS ctDNA fragments</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in plasma concentration of long (~ 290bp) fragments of ACTB gene</measure>
    <time_frame>Nine timepoints between Day-1 to Day 3</time_frame>
    <description>ng/mL in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma concentration of short (~ 145bp) fragments of KRAS gene</measure>
    <time_frame>Nine timepoints between Day-1 to Day 3</time_frame>
    <description>ng/mL in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma concentration of long (~ 300bp) fragments of KRAS gene</measure>
    <time_frame>Nine timepoints between Day-1 to Day 3</time_frame>
    <description>ng/mL in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma concentration of mutant KRAS DNA fragments</measure>
    <time_frame>Nine timepoints between Day-1 to Day 3</time_frame>
    <description>ng/mL in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma concentration of BRAF DNA fragments with V600E mutation</measure>
    <time_frame>Nine timepoints between Day-1 to Day 3</time_frame>
    <description>ng/mL in plasma</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Prostate Cancer</condition>
  <condition>Colon Cancer</condition>
  <arm_group>
    <arm_group_label>circulating DNA plasma level test</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood test</intervention_name>
    <description>plasma concentration of circulating DNA of specific genes</description>
    <arm_group_label>circulating DNA plasma level test</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing surgery for non-metastatic solid tumors: colon, breast and prostate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient must have given their free and informed consent and signed the consent&#xD;
             form&#xD;
&#xD;
          -  The patient must be a member or beneficiary of a health insurance plan&#xD;
&#xD;
          -  The patient is aged between 18-75&#xD;
&#xD;
          -  Patient must weigh &gt;40kg&#xD;
&#xD;
          -  The patient will receive adjusted carcinological surgery&#xD;
&#xD;
          -  Indication of curative surgery&#xD;
&#xD;
          -  The patient has already undergone tumoral biopsy prior to surgery&#xD;
&#xD;
          -  The patient has stage M0 cancer of either colon (right or left colonic&#xD;
             adenocarcinoma), prostate (adenocarcinoma) or breast (infiltrating carcinoma)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject is in a period of exclusion determined by a previous study&#xD;
&#xD;
          -  The patient is under safeguard of justice&#xD;
&#xD;
          -  The subject refuses to sign the consent&#xD;
&#xD;
          -  It is impossible to give the subject informed information&#xD;
&#xD;
          -  The patient is pregnant, parturient or breast feeding&#xD;
&#xD;
          -  Chronic alcoholism&#xD;
&#xD;
          -  The patient has received radiotherapy or chemotherapy periopratively&#xD;
&#xD;
          -  Cancer other than colon, breast or prostate&#xD;
&#xD;
          -  The patient has currently or in the past, had a cancerous lesion&#xD;
&#xD;
          -  Neo-adjuvant therapy (immunotherapy, radiotherapy, chemotherapy)&#xD;
&#xD;
          -  Emergency cancer surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nimes</name>
      <address>
        <city>Nîmes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</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>Colonic Neoplasms</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/NCT03284684
org study id: NIMAO/2016/PC-01
nct id: NCT03284684
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to determine the kinetics of perioperative circulating DNA in three
      types of cancer. This first step will enable further studies comparing the potential impact
      of certain techniques or anesthetic products on cancer surgery.
observational model: Case-Only
time perspective: Prospective
measure: Change in concentration of total mutant circulating DNA
time frame: Nine timepoints between Day-1 to Day 3
description: ng/mL in plasma
measure: Change in proportion of mutant circulating DNA
time frame: Nine timepoints between Day-1 to Day 3
description: ng/mL in plasma
measure: Change in integrity index of circulating DNA for ACTB gene
time frame: Nine timepoints between Day-1 to Day 3
description: concentration of long ACTB ctDNA fragments/concentration of short ACTB ctDNA fragments
measure: Change in integrity index of circulating DNA for KRAS gene
time frame: Nine timepoints between Day-1 to Day 3
description: concentration of long KRAS ctDNA fragments/concentration of short KRAS ctDNA fragments
measure: Change in plasma concentration of long (~ 290bp) fragments of ACTB gene
time frame: Nine timepoints between Day-1 to Day 3
description: ng/mL in plasma
measure: Change in plasma concentration of short (~ 145bp) fragments of KRAS gene
time frame: Nine timepoints between Day-1 to Day 3
description: ng/mL in plasma
measure: Change in plasma concentration of long (~ 300bp) fragments of KRAS gene
time frame: Nine timepoints between Day-1 to Day 3
description: ng/mL in plasma
measure: Change in plasma concentration of mutant KRAS DNA fragments
time frame: Nine timepoints between Day-1 to Day 3
description: ng/mL in plasma
measure: Change in plasma concentration of BRAF DNA fragments with V600E mutation
time frame: Nine timepoints between Day-1 to Day 3
description: ng/mL in plasma
arm group label: circulating DNA plasma level test
intervention type: Other
intervention name: Blood test
description: plasma concentration of circulating DNA of specific genes
arm group label: circulating DNA plasma level test
Blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Colonic Neoplasms
sharing ipd: No