<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/NCT01706809</url>
  </required_header>
  <id_info>
    <org_study_id>S-20100006</org_study_id>
    <secondary_id>S-20100006</secondary_id>
    <nct_id>NCT01706809</nct_id>
  </id_info>
  <brief_title>Comparing of Different Biomarkers From Vena Rectalis Superior and Vena Cubiti in Patients Undergoing Low Anterior Resection for Rectum Cancer</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of the present study is to investigate different biomarkers like VEGF, EVGF&#xD;
      and others ability to predict time to recidive and progressions free survival.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients undergoing LAR for rectum cancer is subjected. Preoperative blood samples from vena&#xD;
      rectalis superior and vena cubiti is collected, as well as biopsies from tumor. Preoperative&#xD;
      and after 3 month peripheral blood samples is collected.&#xD;
&#xD;
      A total of 50 patients will be included in this study.&#xD;
&#xD;
      The study is approved by the local scientific ethical committee No. S-20100006&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2011</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The primary aim of the present study is to investigate different biomarkers like VEGF, EVGF and others ability to predict time to recidive and progressions free survival.</measure>
    <time_frame>after the study is complete</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>Biomarkeres</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood sampels from vena rectalis superior and vena cubiti</intervention_name>
    <arm_group_label>Biomarkeres</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing open LAR for rectum cancer is subjected.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological verified cancer&#xD;
&#xD;
          -  The cancer must be located in rectum maximum of 15 cm.&#xD;
&#xD;
          -  Age above 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Disseminated cancer&#xD;
&#xD;
          -  Perioperative radio-chemotherapy&#xD;
&#xD;
          -  Laparoscopy surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Vejle hospital</name>
      <address>
        <city>Vejle</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hans Rahr, MD</last_name>
      <phone>7940 5600</phone>
      <phone_ext>0045</phone_ext>
      <email>hans.rahr@slb.regionsyddanmark.dk</email>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>February 4, 2014</last_update_submitted>
  <last_update_submitted_qc>February 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Mark Ellebaek Pedersen</investigator_full_name>
    <investigator_title>Medical doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal 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/NCT01706809
org study id: S-20100006
secondary id: S-20100006
nct id: NCT01706809
lead sponsor: 
has dmc: No
The primary aim of the present study is to investigate different biomarkers like VEGF, EVGF
      and others ability to predict time to recidive and progressions free survival.
Patients undergoing LAR for rectum cancer is subjected. Preoperative blood samples from vena
      rectalis superior and vena cubiti is collected, as well as biopsies from tumor. Preoperative
      and after 3 month peripheral blood samples is collected.

      A total of 50 patients will be included in this study.

      The study is approved by the local scientific ethical committee No. S-20100006
observational model: Case-Control
time perspective: Prospective
measure: The primary aim of the present study is to investigate different biomarkers like VEGF, EVGF and others ability to predict time to recidive and progressions free survival.
time frame: after the study is complete
arm group label: Biomarkeres
intervention type: Other
intervention name: blood sampels from vena rectalis superior and vena cubiti
arm group label: Biomarkeres
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Odense University Hospital
investigator full name: Mark Ellebaek Pedersen
investigator title: Medical doctor
mesh term: Rectal Neoplasms