<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/NCT02970760</url>
  </required_header>
  <id_info>
    <org_study_id>CAMP</org_study_id>
    <nct_id>NCT02970760</nct_id>
  </id_info>
  <brief_title>Computer Assisted Measurement of Colorectal Polyps</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Technical University of Munich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adenomas are polyps of the colorectum that have the potential to develop into colon cancer.&#xD;
      However, some adenomas never become malignant tumors, or if so, progression from adenoma into&#xD;
      cancer takes a long time. As a result, screening colonoscopy programs were established in&#xD;
      order to detect and resect adenomas at an early stage. After resection, polyps should be sent&#xD;
      to pathology in order to make a histological diagnosis. Approximately 40-50% of all polyps&#xD;
      have adenomatous histology whereas others contain benign histology (e.g. hyperplastic or&#xD;
      inflammatory polyps). The latter polyps do not bear the risk to develop colon cancer.&#xD;
&#xD;
      The bigger a polyp is the greater the chance is of it being malignant. During colonoscopy&#xD;
      polyp size can be estimated visually by comparing the polyp with an opened biopsy forceps.&#xD;
      The span of an opened forceps is 7 mm. Prior to using this technique, the forceps has to be&#xD;
      inserted into the colon through a small working channel of the endoscope. Information on the&#xD;
      actual adenoma size is crucial as surveillance recommendations depend on the size of the&#xD;
      resected polyps. Moreover current guidelines contain the possibilities to disregard&#xD;
      hyperplastic polyps in the sigmoid colon if the polyp size is below 5 mm. This means that&#xD;
      diminutive hyperplastic polyps (&lt; 5mm) do not necessarily require resection due to their&#xD;
      benign dignity. However, there is increasing evidence that large human bias effects exist in&#xD;
      estimating the size of polypoid lesions. For example, it has been shown that endoscopists&#xD;
      exhibit terminal digit preferences leading to an exaggeration of estimated polyp size. In&#xD;
      consequence the human bias problem might lead to wrong adenoma surveillance decisions.&#xD;
&#xD;
      There is no doubt that technical devices are needed which can support endoscopists in finding&#xD;
      the right declaration of polyp sizes. The aim of the current project is to create a computer&#xD;
      program that is able to automatically measure polyp sizes during colonoscopy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">April 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>Polyp size as assessed by the computer program</measure>
    <time_frame>up to 2 weeks</time_frame>
    <description>The predicted polyp size (made by the computer program) will be assessed; the size will be compared with the actual polyp size (as assessed by endoscopist = gold standard). Participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks</description>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Colonic Polyp</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Colonic polyps&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing colonoscopy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  indication for colonoscopy&#xD;
&#xD;
          -  patients &gt;= 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  indication for colonoscopy: inflammatory bowel disease&#xD;
&#xD;
          -  indication for colonoscopy: polyposis syndrome&#xD;
&#xD;
          -  indication for colonoscopy: emergency colonoscopy e.g. acute bleeding&#xD;
&#xD;
          -  contraindication for polyp resection e.g. patients on warfarin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Peter Klare, MD</last_name>
    <phone>+ 49 89 4140</phone>
    <phone_ext>9340</phone_ext>
    <email>peter.klare@tum.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München</name>
      <address>
        <city>Munich</city>
        <state>Bayern</state>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
    <contact>
      <last_name>Peter Klare, MD</last_name>
      <phone>+ 49 89 4140</phone>
      <phone_ext>9340</phone_ext>
      <email>peter.klare@tum.de</email>
    </contact>
    <contact_backup>
      <last_name>Stefan von Delius, Prof.</last_name>
      <phone>+ 49 89 4140</phone>
      <phone_ext>5973</phone_ext>
      <email>stefan_ruckert@yahoo.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>November 18, 2016</last_update_submitted>
  <last_update_submitted_qc>November 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polyps</mesh_term>
    <mesh_term>Colonic Polyps</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02970760
org study id: CAMP
nct id: NCT02970760
lead sponsor: 
has dmc: No
Adenomas are polyps of the colorectum that have the potential to develop into colon cancer.
      However, some adenomas never become malignant tumors, or if so, progression from adenoma into
      cancer takes a long time. As a result, screening colonoscopy programs were established in
      order to detect and resect adenomas at an early stage. After resection, polyps should be sent
      to pathology in order to make a histological diagnosis. Approximately 40-50% of all polyps
      have adenomatous histology whereas others contain benign histology (e.g. hyperplastic or
      inflammatory polyps). The latter polyps do not bear the risk to develop colon cancer.

      The bigger a polyp is the greater the chance is of it being malignant. During colonoscopy
      polyp size can be estimated visually by comparing the polyp with an opened biopsy forceps.
      The span of an opened forceps is 7 mm. Prior to using this technique, the forceps has to be
      inserted into the colon through a small working channel of the endoscope. Information on the
      actual adenoma size is crucial as surveillance recommendations depend on the size of the
      resected polyps. Moreover current guidelines contain the possibilities to disregard
      hyperplastic polyps in the sigmoid colon if the polyp size is below 5 mm. This means that
      diminutive hyperplastic polyps (< 5mm) do not necessarily require resection due to their
      benign dignity. However, there is increasing evidence that large human bias effects exist in
      estimating the size of polypoid lesions. For example, it has been shown that endoscopists
      exhibit terminal digit preferences leading to an exaggeration of estimated polyp size. In
      consequence the human bias problem might lead to wrong adenoma surveillance decisions.

      There is no doubt that technical devices are needed which can support endoscopists in finding
      the right declaration of polyp sizes. The aim of the current project is to create a computer
      program that is able to automatically measure polyp sizes during colonoscopy.
observational model: Cohort
time perspective: Prospective
measure: Polyp size as assessed by the computer program
time frame: up to 2 weeks
description: The predicted polyp size (made by the computer program) will be assessed; the size will be compared with the actual polyp size (as assessed by endoscopist = gold standard). Participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks
Colonic polyps
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Peter Klare, MD
phone: + 49 89 4140
phone ext: 9340
email: peter.klare@tum.de
facility: 
contact: 
contact backup: 
country: Germany
responsible party type: Sponsor
mesh term: Polyps
mesh term: Colonic Polyps
sharing ipd: No