<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/NCT01712958</url>
  </required_header>
  <id_info>
    <org_study_id>0148</org_study_id>
    <nct_id>NCT01712958</nct_id>
  </id_info>
  <brief_title>Quantifying Micro RNA Levels of Colon</brief_title>
  <acronym>CRC</acronym>
  <official_title>Quantifying Micro RNA Levels to Obtain a Micro RNA Signature of Colon Tumor Phenotypes and Sub Phenotypes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meir Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Colorectal cancer (CRC) is the third most common cancer and the fourth leading cause of&#xD;
      cancer-related death in the world. Despite potentially curative surgery and the use of modern&#xD;
      adjuvant chemotherapy, up to 40% of CRC patients subsequently develop local tumor relapse or&#xD;
      metastatic disease. Currently, aside from post-operative pathological staging, early follow&#xD;
      up of the patients does not include a specific test or any other evaluation that could&#xD;
      predict disease recurrence. Therefore, exploring and identifying novel biomarkers of CRC's&#xD;
      following diagnosis of the primary tumor may help us in identifying patients at high risk for&#xD;
      recurrence.&#xD;
&#xD;
      Modifications in signaling pathways and their regulation by microRNAs (miRNAs) are being&#xD;
      evaluated as biomarkers and therapeutic targets for cancer in general and CRC in particular.&#xD;
      It has been established, although not completely, that miRNAs have a role in initiation and&#xD;
      progression of CRC. Modifications of miRNAs have been recorded in CRC tumors, and the&#xD;
      expression patterns of these miRNAs could in principle biomark this cancer's phenotype. As&#xD;
      miRNAs are well documented to regulate critical molecules in signaling pathways, their&#xD;
      regulation of tumor relevant pathways may also serve to further sub-classify patients into&#xD;
      drug responsive groups. Moreover, miRNAs may be sampled from peripheral blood and are&#xD;
      available as a non-invasive diagnostic method, their application as biomarkers is of special&#xD;
      interest.&#xD;
&#xD;
      In this study the investigators aim to quantify miRNA levels in human colon and rectal&#xD;
      tumors, tumor adjacent and normal tissues. By comparing this data from a large cohort of&#xD;
      patients, the investigators aim to identify specific, relevant miRNAs that may serve as&#xD;
      biomarkers to stratify CRC patients according to their clinical characteristics such as&#xD;
      disease stage, specific treatment, prognosis and disease recurrence.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">November 2015</completion_date>
  <primary_completion_date type="Anticipated">November 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>identifying specific, relevant miRNAs that may serve as biomarkers to stratify CRC patients according to their clinical characteristics</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Colorectal Carcinoma (CRC) Patients</condition>
  <biospec_descr>
    <textblock>
      human colon and rectal tumors, tumor adjacent and normal tissues&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        CRC patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adult men and women over the age of 18 years who underwent colon resection of any kind are&#xD;
        suitable candidates for this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Pregnant woman and children (under the age of 18 years) will not be included in this study.&#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>Shmuel Avital, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Meir Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shmuel Avital, M.D</last_name>
    <phone>972-9-7472162</phone>
    <phone_ext>2162</phone_ext>
    <email>avitalshmuel@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Meir Medical Center</name>
      <address>
        <city>Kfar-Saba</city>
        <zip>44281</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <phone>972-9-7471753</phone>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 21, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>October 23, 2012</last_update_submitted>
  <last_update_submitted_qc>October 23, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 24, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CRC miRNA</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/NCT01712958
org study id: 0148
nct id: NCT01712958
lead sponsor: 
has dmc: Yes
Colorectal cancer (CRC) is the third most common cancer and the fourth leading cause of
      cancer-related death in the world. Despite potentially curative surgery and the use of modern
      adjuvant chemotherapy, up to 40% of CRC patients subsequently develop local tumor relapse or
      metastatic disease. Currently, aside from post-operative pathological staging, early follow
      up of the patients does not include a specific test or any other evaluation that could
      predict disease recurrence. Therefore, exploring and identifying novel biomarkers of CRC's
      following diagnosis of the primary tumor may help us in identifying patients at high risk for
      recurrence.

      Modifications in signaling pathways and their regulation by microRNAs (miRNAs) are being
      evaluated as biomarkers and therapeutic targets for cancer in general and CRC in particular.
      It has been established, although not completely, that miRNAs have a role in initiation and
      progression of CRC. Modifications of miRNAs have been recorded in CRC tumors, and the
      expression patterns of these miRNAs could in principle biomark this cancer's phenotype. As
      miRNAs are well documented to regulate critical molecules in signaling pathways, their
      regulation of tumor relevant pathways may also serve to further sub-classify patients into
      drug responsive groups. Moreover, miRNAs may be sampled from peripheral blood and are
      available as a non-invasive diagnostic method, their application as biomarkers is of special
      interest.

      In this study the investigators aim to quantify miRNA levels in human colon and rectal
      tumors, tumor adjacent and normal tissues. By comparing this data from a large cohort of
      patients, the investigators aim to identify specific, relevant miRNAs that may serve as
      biomarkers to stratify CRC patients according to their clinical characteristics such as
      disease stage, specific treatment, prognosis and disease recurrence.
observational model: Cohort
time perspective: Retrospective
measure: identifying specific, relevant miRNAs that may serve as biomarkers to stratify CRC patients according to their clinical characteristics
time frame: 3 years
human colon and rectal tumors, tumor adjacent and normal tissues
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shmuel Avital, M.D.
role: Principal Investigator
affiliation: Meir Medical Center
last name: Shmuel Avital, M.D
phone: 972-9-7472162
phone ext: 2162
email: avitalshmuel@gmail.com
facility: 
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Colorectal Neoplasms