<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/NCT01693861</url>
  </required_header>
  <id_info>
    <org_study_id>C11-59</org_study_id>
    <secondary_id>2012-A00168-35</secondary_id>
    <nct_id>NCT01693861</nct_id>
  </id_info>
  <brief_title>&quot;Cancersensor&quot; Chemotherapy</brief_title>
  <official_title>Molecularly Imprinted Polymer Sensors of Modified Nucleosides for Non-invasive Monitoring of Cancer Therapy : Effect of Chemotherapy on Cancerous Proliferation Based on the Dynamic Excretion of Urinary Nucleosides.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut National de la Santé Et de la Recherche Médicale, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Observational, non randomized study aimed at measuring the effect of chemotherapy in the&#xD;
      urinary concentrations of physiological modified nucleosides in 30 patients with metastatic&#xD;
      colorectal cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Effect of chemotherapy on urinary excretion of modified nucleosides</measure>
    <time_frame>17 days</time_frame>
    <description>1 urine sample per day 3 days before and 14 days after beginning of chemotherapy Measurement of modified nucleosides, cortisol and 6-sulfatoxymelatonin concentration&#xD;
1 saliva sample : Measurement of Clock genes polymorphisms expression</description>
  </primary_outcome>
  <other_outcome>
    <measure>Identification of modified nucleosides as biomarkers for colorectal cancer</measure>
    <time_frame>17 days</time_frame>
    <description>Measurement of modified nucleosides, cortisol and 6-sulfatoxymelatonin concentration in urine samples before and after chemotherapy&#xD;
1 saliva sample Measurement of Clock genes polymorphisms expression</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">16</enrollment>
  <condition>Metastatic Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>Patients with metastatic colorectal cancer treated with chemotherapy</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Urine and exfoliated oral mucosa cells&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with metastatic colorectal cancer treated at the Department of Medical Oncology of&#xD;
        Paul Brousse Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically-confirmed metastatic colorectal cancer;&#xD;
&#xD;
          -  0 to 3 prior chemotherapy lines;&#xD;
&#xD;
          -  Signed informed consent;&#xD;
&#xD;
          -  Good understanding of the protocol and of the follow-up;&#xD;
&#xD;
          -  Estimated life expectancy exceeding 3 months;&#xD;
&#xD;
          -  At least one measurable metastatic lesion (RECIST criteria);&#xD;
&#xD;
          -  Performance Status (WHO) of 0 to 2;&#xD;
&#xD;
          -  Good haematological, hepatic and renal functions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  More than 2 surgical resections of metastases from colorectal cancer;&#xD;
&#xD;
          -  Poor performance status (&gt;2);&#xD;
&#xD;
          -  Poor haematological, hepatic or renal functions;&#xD;
&#xD;
          -  Uncontrolled chronic disease;&#xD;
&#xD;
          -  Serious unhealed wound, ulcer or fracture within the previous month;&#xD;
&#xD;
          -  Clinical or laboratory finding suggesting possible abnormalities in nucleosides&#xD;
             urinary excretion;&#xD;
&#xD;
          -  Pregnancy or breast-feeding during the previous month;&#xD;
&#xD;
          -  Transmeridian trip of more than 4 time zones within the prior 2 weeks;&#xD;
&#xD;
          -  Person with legal restriction to participate into clinical research, according to the&#xD;
             current law in France.&#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>Francis Lévi, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>INSERM CNRS AP-HP Université Paris Sud</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Paul Brousse Hospital</name>
      <address>
        <city>Villejuif</city>
        <zip>94807</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colorectal</keyword>
  <keyword>Cancer</keyword>
  <keyword>Metastatic</keyword>
  <keyword>Chronotherapy</keyword>
  <keyword>Urine</keyword>
  <keyword>Nucleosides</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>Treated with chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT01693861
org study id: C11-59
secondary id: 2012-A00168-35
nct id: NCT01693861
lead sponsor: 
has dmc: No
Observational, non randomized study aimed at measuring the effect of chemotherapy in the
      urinary concentrations of physiological modified nucleosides in 30 patients with metastatic
      colorectal cancer.
observational model: Case-Only
time perspective: Prospective
measure: Effect of chemotherapy on urinary excretion of modified nucleosides
time frame: 17 days
description: 1 urine sample per day 3 days before and 14 days after beginning of chemotherapy Measurement of modified nucleosides, cortisol and 6-sulfatoxymelatonin concentration
1 saliva sample : Measurement of Clock genes polymorphisms expression
measure: Identification of modified nucleosides as biomarkers for colorectal cancer
time frame: 17 days
description: Measurement of modified nucleosides, cortisol and 6-sulfatoxymelatonin concentration in urine samples before and after chemotherapy
1 saliva sample Measurement of Clock genes polymorphisms expression
arm group label: Patients
description: Patients with metastatic colorectal cancer treated with chemotherapy
Urine and exfoliated oral mucosa cells
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Francis Lévi, MD PhD
role: Principal Investigator
affiliation: INSERM CNRS AP-HP Université Paris Sud
facility: 
country: France
responsible party type: Sponsor
mesh term: Colorectal Neoplasms