<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/NCT02193646</url>
  </required_header>
  <id_info>
    <org_study_id>ESA-2014</org_study_id>
    <nct_id>NCT02193646</nct_id>
  </id_info>
  <brief_title>Endoscopic Size Assessment of Advanced Adenomatous Polyps</brief_title>
  <official_title>Endoscopic Size Assessment of Advanced Adenomatous Polyps; Inter Observer Variations</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 investigators are retrospectively comparing detection rates of adenomatous polyps,&#xD;
      advanced adenomas, and size assessment of the polyps among Rush University Medical Center&#xD;
      endoscopists. The investigators plan to review whether the size assessment of adenomatous&#xD;
      polyps affected the surveillance protocols and if the location of polyps detected affected&#xD;
      the detection rates.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 2010</start_date>
  <completion_date type="Anticipated">January 2026</completion_date>
  <primary_completion_date type="Anticipated">January 2026</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Adenomatous Polyp Detection Rate</measure>
    <time_frame>one year</time_frame>
    <description>Assessing for advanced adenomas (including location).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Endoscopic Size Assessment Versus Pathological Size Assessment</measure>
    <time_frame>one year</time_frame>
    <description>Size of polyps at time of endoscopic procedure will be compared to the size of the same polyp by pathological assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Retroflexion as an indication of adenoma detection rate in colorectal cancer screening</measure>
    <time_frame>one year</time_frame>
    <description>Retroflexion is a common but not mandatory practice in colonoscopy which as not been systematically studied in terms of polyp detection. Charts will be reviewed to determine whether retroflexion was performed.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Adenoma Detection Rate Improvement in Screening Colonoscopy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects undergoing screening colonoscopies at Rush University Medical Center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of adenomatous polyps detected at endoscopy and diagnosed pathologically by&#xD;
             tissue biopsy&#xD;
&#xD;
          -  Have a colonoscopy at RUMC for screening purposes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Failure to meet inclusion criteria&#xD;
&#xD;
          -  Previous diagnosis of IBD or colorectal cancer&#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>
  <overall_contact>
    <last_name>Amanda Lin</last_name>
    <phone>3125633907</phone>
    <email>amanda_f_lin@rush.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>GI Research</last_name>
    <phone>312-942-3466</phone>
    <email>gi_research@rush.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Amanda Lin</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amanda Lin</last_name>
      <phone>312-563-3907</phone>
      <email>amanda_f_lin@rush.edu</email>
    </contact>
    <contact_backup>
      <last_name>Solomon Adelowo</last_name>
      <phone>843-597-4268</phone>
      <email>Solomon_O_Adelowo@rush.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Salina Lee, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Joshua Melson, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Muhammad Alsayid, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Faraz Bishehsari, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>November 1, 2022</last_update_submitted>
  <last_update_submitted_qc>November 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colonoscopy</keyword>
  <keyword>Adenoma</keyword>
  <keyword>ADR</keyword>
  <keyword>Screening Colon Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Adenomatous 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/NCT02193646
org study id: ESA-2014
nct id: NCT02193646
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators are retrospectively comparing detection rates of adenomatous polyps,
      advanced adenomas, and size assessment of the polyps among Rush University Medical Center
      endoscopists. The investigators plan to review whether the size assessment of adenomatous
      polyps affected the surveillance protocols and if the location of polyps detected affected
      the detection rates.
observational model: Case-Only
time perspective: Retrospective
measure: Adenomatous Polyp Detection Rate
time frame: one year
description: Assessing for advanced adenomas (including location).
measure: Endoscopic Size Assessment Versus Pathological Size Assessment
time frame: one year
description: Size of polyps at time of endoscopic procedure will be compared to the size of the same polyp by pathological assessment.
measure: Retroflexion as an indication of adenoma detection rate in colorectal cancer screening
time frame: one year
description: Retroflexion is a common but not mandatory practice in colonoscopy which as not been systematically studied in terms of polyp detection. Charts will be reviewed to determine whether retroflexion was performed.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amanda Lin
phone: 3125633907
email: amanda_f_lin@rush.edu
last name: GI Research
phone: 312-942-3466
email: gi_research@rush.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Adenoma
mesh term: Adenomatous Polyps