<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/NCT02217085</url>
  </required_header>
  <id_info>
    <org_study_id>RSA-RTSC 2014</org_study_id>
    <nct_id>NCT02217085</nct_id>
  </id_info>
  <brief_title>Colorectal Polyp Resection Adequacy</brief_title>
  <official_title>Determining True Colorectal Polyp Resection Adequacy: Correlation of Endoscopic Margins With Histopathologic Margins</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rush University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rush University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the best way to ensure that polyps are completely&#xD;
      removed by evaluating the borders of the removed polyp. If a polyp is found that meets the&#xD;
      size requirements for the study, the investigators will take extra biopsies of the margin to&#xD;
      determine if there is any abnormal tissue or cancer at these borders.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The incomplete resection rates in polyps from Group 1 (clear margins) versus Group 2 (positive margins).</measure>
    <time_frame>Between 3-6 months</time_frame>
    <description>Define the frequency of free margins versus margins that have dysplasia to the cautery site in snare polypectomy. A free margin is defined as uninvolved or normal mucosa extending to the cautery margin at the polypectomy stalk.</description>
  </primary_outcome>
  <enrollment type="Actual">288</enrollment>
  <condition>Polyp Resection Adequacy</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Polyp margins will be biopsied and retained.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adults aged 40 to 80 who are undergoing screening or surveillance colonoscopy for&#xD;
        colorectal adenomatous polyps.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 40-80&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Coagulopathy (international normalized ratio &gt;2)&#xD;
&#xD;
          -  Inflammatory bowel disease or other active colitides&#xD;
&#xD;
          -  Polyps of index colonoscopy that were felt not to be completely resected or&#xD;
             pedunculated&#xD;
&#xD;
          -  Familial adenomatous polyposis or hereditary polyposis&#xD;
&#xD;
          -  Potential hereditary cancer syndrome (Lynch Syndrome)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>August 19, 2022</last_update_submitted>
  <last_update_submitted_qc>August 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colorectal Cancer Screening</keyword>
  <keyword>Colon Cancer Screening</keyword>
  <keyword>Polyps</keyword>
  <keyword>Colonoscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polyps</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/NCT02217085
org study id: RSA-RTSC 2014
nct id: NCT02217085
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the best way to ensure that polyps are completely
      removed by evaluating the borders of the removed polyp. If a polyp is found that meets the
      size requirements for the study, the investigators will take extra biopsies of the margin to
      determine if there is any abnormal tissue or cancer at these borders.
observational model: Cohort
time perspective: Prospective
measure: The incomplete resection rates in polyps from Group 1 (clear margins) versus Group 2 (positive margins).
time frame: Between 3-6 months
description: Define the frequency of free margins versus margins that have dysplasia to the cautery site in snare polypectomy. A free margin is defined as uninvolved or normal mucosa extending to the cautery margin at the polypectomy stalk.
Polyp margins will be biopsied and retained.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Polyps