<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/NCT01713881</url>
  </required_header>
  <id_info>
    <org_study_id>DDEAMC-Fincher 1</org_study_id>
    <nct_id>NCT01713881</nct_id>
  </id_info>
  <brief_title>Effect of a Tracking Program on Colon Adenoma Surveillance and Adherence to Guideline Recommendations</brief_title>
  <official_title>Effect of a Tracking Program on Colon Adenoma Surveillance and Adherence to Guideline Recommendations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>United States Department of Defense</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be a retrospective chart review of 880-1000 patients who had a colonoscopy and were&#xD;
      found to have a tubular adenoma between the years of 2004-2008. We will compare the rate and&#xD;
      timing of completion of repeat colonoscopies pre and post establishment of a polyp registry&#xD;
      (tracking system) in 2006. Each group will be composed of up to 500 subjects consecutively&#xD;
      identified from all the patients who underwent colonoscopy and were found to have a tubular&#xD;
      adenoma (Group 1-2004 to 2006, Group 2 2007-2008).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a retrospective chart review of 880-1000 patients who had a colonoscopy and were&#xD;
      found to have a tubular adenoma between the years of 2004-2008. We will compare the rate and&#xD;
      timing of completion of repeat colonoscopies pre and post establishment of a polyp registry&#xD;
      (tracking system) in 2006. Each group will be composed of 380-500 subjects consecutively&#xD;
      identified from all the patients who underwent colonoscopy and were found to have a tubular&#xD;
      adenoma (Group 1-2004 to 2006, Group 2 2007-2008).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">June 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Percentage completing follow up colonoscopy</measure>
    <time_frame>12 months</time_frame>
    <description>A polyp tracking program (registry) decreases the amount of patients lost to follow up.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Colon Polyp Surveillance</condition>
  <arm_group>
    <arm_group_label>post-registry</arm_group_label>
    <description>Registry Group:&#xD;
Select 500 consecutive patients from the polyp registry who were found to have a tubular adenoma on a colonoscopy done between 2007-2008 from the polyp registry.&#xD;
Quantify the completion rate and time between index and surveillance colonoscopy after the establishment of the polyp surveillance program (2006-2013).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pre-registry</arm_group_label>
    <description>Pre-registry Group: Select 380 consecutive patients who were found to have a tubular adenoma on a colonoscopy done between April 2004-Nov 2006.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with colon polyps&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any adenoma found on screening/surveillance colonoscopy (ICD9-211.3, Procedure code&#xD;
             45385 or 45380)&#xD;
&#xD;
          -  Greater than 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 years old&#xD;
&#xD;
          -  Diagnosis of IBD&#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>D.D. Eisenhower Army Medical Center</name>
      <address>
        <city>Fort Gordon</city>
        <state>Georgia</state>
        <zip>30905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>March 19, 2014</last_update_submitted>
  <last_update_submitted_qc>March 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>United States Department of Defense</investigator_affiliation>
    <investigator_full_name>R. Keith Fincher, MD, FACP, FACG</investigator_full_name>
    <investigator_title>Gastroenterologist</investigator_title>
  </responsible_party>
  <keyword>Polyp</keyword>
  <keyword>colonoscopy</keyword>
  <keyword>surveillance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</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/NCT01713881
org study id: DDEAMC-Fincher 1
nct id: NCT01713881
lead sponsor: 
has dmc: No
This will be a retrospective chart review of 880-1000 patients who had a colonoscopy and were
      found to have a tubular adenoma between the years of 2004-2008. We will compare the rate and
      timing of completion of repeat colonoscopies pre and post establishment of a polyp registry
      (tracking system) in 2006. Each group will be composed of up to 500 subjects consecutively
      identified from all the patients who underwent colonoscopy and were found to have a tubular
      adenoma (Group 1-2004 to 2006, Group 2 2007-2008).
This will be a retrospective chart review of 880-1000 patients who had a colonoscopy and were
      found to have a tubular adenoma between the years of 2004-2008. We will compare the rate and
      timing of completion of repeat colonoscopies pre and post establishment of a polyp registry
      (tracking system) in 2006. Each group will be composed of 380-500 subjects consecutively
      identified from all the patients who underwent colonoscopy and were found to have a tubular
      adenoma (Group 1-2004 to 2006, Group 2 2007-2008).
observational model: Cohort
time perspective: Retrospective
measure: Percentage completing follow up colonoscopy
time frame: 12 months
description: A polyp tracking program (registry) decreases the amount of patients lost to follow up.
arm group label: post-registry
description: Registry Group:
Select 500 consecutive patients from the polyp registry who were found to have a tubular adenoma on a colonoscopy done between 2007-2008 from the polyp registry.
Quantify the completion rate and time between index and surveillance colonoscopy after the establishment of the polyp surveillance program (2006-2013).
arm group label: pre-registry
description: Pre-registry Group: Select 380 consecutive patients who were found to have a tubular adenoma on a colonoscopy done between April 2004-Nov 2006.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: United States Department of Defense
investigator full name: R. Keith Fincher, MD, FACP, FACG
investigator title: Gastroenterologist
mesh term: Adenoma