<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/NCT02263144</url>
  </required_header>
  <id_info>
    <org_study_id>REDEFINE</org_study_id>
    <nct_id>NCT02263144</nct_id>
  </id_info>
  <brief_title>Resect and Discard Extension to FICE of NIcE Classification</brief_title>
  <acronym>FICE;NICE</acronym>
  <official_title>Resect and Discard Extension to Fuji Intelligent Color Enhancement (FICE) of Narrow Band Imaging International Colorectal Endoscopic (NicE) Classification</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Clinico Humanitas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Royal Alexandra Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nuovo Regina Margherita Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Erlangen-Nürnberg Medical School</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Regensburg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hôpital Edouard Herriot</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istituto Clinico Humanitas</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this prospective, non-interventional study is to validate the Narrow Band&#xD;
      Imaging International Colorectal Endoscopic (NICE) classification for differentiating&#xD;
      subcentimetric hyperplastic and adenomatous polyps by using Fuji Intelligent Color&#xD;
      Enhancement (FICE) technology with high-definition without optical magnification.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. In order to create a video-library of endoscopic cases, patients undergoing screening or&#xD;
           diagnostic colonoscopy will be considered for inclusion. Patients with at least one&#xD;
           histologically verified &lt;10 mm polyp will be included. A short video-clip (around 15-20&#xD;
           seconds) of each polyp both at white-light and FICE-light will be recorded and stored in&#xD;
           an anonymized database.&#xD;
&#xD;
        2. Once the video-library is completed, each of 7 experts will independently review all the&#xD;
           cases. For each case, any observer will assess each of the three NICE criteria&#xD;
           (colour/vascularization/surface), the degree of confidence (low/high), and classify the&#xD;
           lesion as neoplastic or non-neoplastic. The primary outcomes are the accuracy of FICE&#xD;
           technology with high-definition and without magnification, when adopting NICE&#xD;
           classification, to differentiate between hyperplastic and adenomatous lesions, and the&#xD;
           inter-observer agreement in such differentiation. Secondary end-points are to assess at&#xD;
           multivariate measure the role of any individual criteria of NICE classification in the&#xD;
           discrimination between the two histotypes, and possible adaptations of NICE&#xD;
           classification in order to be applied with FICE.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2014</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>accuracy of the NICE criteria using FICE technology for differentiating between the non-neoplastic and neoplastic histotypes in diagnoses with high-confidence on a video-library of 110 polyps reviewed by 7 experts.</measure>
    <time_frame>up to 6 months</time_frame>
    <description>7 experts will review videos from a video-library of subcentimetric polyps removed and histologically verified and will assess each of the three NICE criteria (colour/vascularization/surface), and classify the lesion as neoplastic or non-neoplastic with low or high confidence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inter-observer agreement among the 7 experts</measure>
    <time_frame>up to 6 months</time_frame>
    <description>The inter-observer agreement, among the 7 experts, on the final diagnosis (neoplastic or non-neoplastic) and on each individual NICE criterion for each polyp will be determined by using K statistics .</description>
  </primary_outcome>
  <other_outcome>
    <measure>Accuracy of additional criteria, such as the presence of mucus, to differentiate between sub-types of non-neoplastic lesions (i.e. serrated lesions)</measure>
    <time_frame>up to 6 month</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Hyperplastic Polyps</condition>
  <condition>Adenomatous Polyps</condition>
  <arm_group>
    <arm_group_label>histologically-verified &lt;10mm polyps</arm_group_label>
    <description>histologically-verified &lt;10mm polyps, analyzed by virtual chromo-endoscopy using FICE Fujifilm Technology</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>virtual chromo-endoscopy using FICE Fujifilm Technology</intervention_name>
    <description>For each polyps, any observer will use virtual chromo-endoscopy with FICE Fujifilm Technology</description>
    <arm_group_label>histologically-verified &lt;10mm polyps</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      colonic polyps&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive adult patients who were referred for elective outpatient colonoscopy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patient is undergoing colonoscopy for screening, for surveillance in follow-up of&#xD;
             previous polypectomy or for diagnostic work-up;&#xD;
&#xD;
          2. The patient is at satisfactory risk to undergo abdominal surgery;&#xD;
&#xD;
          3. The patient must understand and provide written consent for the procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with inflammatory bowel disease;&#xD;
&#xD;
          2. Patients with a personal history of polyposis syndrome;&#xD;
&#xD;
          3. Patients with diverticulitis or toxic megacolon;&#xD;
&#xD;
          4. Patients with a history of radiation therapy to abdomen or pelvis.&#xD;
&#xD;
          5. Patients with a history of severe cardiovascular, pulmonary, liver or renal disease;&#xD;
&#xD;
          6. Personal history of coagulation disorders or use of anticoagulants&#xD;
&#xD;
          7. Patients who are currently enrolled in another clinical investigation in which the&#xD;
             intervention might compromise the safety of the patient's participation in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alessandro Repici, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istituto Clinico Humanitas</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alessandro Repici, MD</last_name>
    <phone>+39282247493</phone>
    <email>alessandro.repici@humanitas.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Dept of Gastroenterology and Endoscopy, University Hospital</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raf Bisschops, MD</last_name>
      <email>raf.bisschops@med.kuleuven.be</email>
    </contact>
    <investigator>
      <last_name>Raf Bisschops, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dept of Gastroenterology, Edouard Herriot Hospital, Hospices Civils of Lyon</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thierry Ponchon, MD</last_name>
      <email>thierry.ponchon@chu-lyon.fr</email>
    </contact>
    <investigator>
      <last_name>Thierry Ponchon, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Department of Medicine I, University of Erlangen-Nürnberg Medical School</name>
      <address>
        <city>Erlangen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Helmut Neumann, MD</last_name>
      <email>helmut.neumann@uk-erlangen.de</email>
    </contact>
    <investigator>
      <last_name>Helmut Neumann, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dept of Gastroenterology and interventional Endoscopy, Krankenhaus Barmherzige Brüder</name>
      <address>
        <city>Regensburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Oliver Pech, MD</last_name>
      <email>oliver.pech@t-online.de</email>
    </contact>
    <investigator>
      <last_name>Oliver Pech, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Endoscopy Unit, Humanitas Research Hospital</name>
      <address>
        <city>Rozzano</city>
        <state>Milano</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alessandro Repici, MD</last_name>
      <phone>+39282247493</phone>
      <email>alessandro.repici@humanitas.it</email>
    </contact>
    <investigator>
      <last_name>Alessandro Repici, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Camilla Ciscato, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Digestive Endoscopy Unit, Nuovo Regina Margherita Hospital</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cesare Hassan, MD</last_name>
      <email>cesareh@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Cesare Hassan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Solent Centre for Digestive Diseases , Royal Alexandra Hospital</name>
      <address>
        <city>Portsmouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pradeep Bhandari, MD</last_name>
      <email>pradeep.bhandari@porthosp.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Pradeep Bhandari, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Hewett DG, Kaltenbach T, Sano Y, Tanaka S, Saunders BP, Ponchon T, Soetikno R, Rex DK. Validation of a simple classification system for endoscopic diagnosis of small colorectal polyps using narrow-band imaging. Gastroenterology. 2012 Sep;143(3):599-607.e1. doi: 10.1053/j.gastro.2012.05.006. Epub 2012 May 15.</citation>
    <PMID>22609383</PMID>
  </reference>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>October 8, 2014</last_update_submitted>
  <last_update_submitted_qc>October 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istituto Clinico Humanitas</investigator_affiliation>
    <investigator_full_name>Michele Tedeschi</investigator_full_name>
    <investigator_title>Responsabile Progetto Ricerca Clinica</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenomatous Polyps</mesh_term>
    <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/NCT02263144
org study id: REDEFINE
nct id: NCT02263144
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this prospective, non-interventional study is to validate the Narrow Band
      Imaging International Colorectal Endoscopic (NICE) classification for differentiating
      subcentimetric hyperplastic and adenomatous polyps by using Fuji Intelligent Color
      Enhancement (FICE) technology with high-definition without optical magnification.
1. In order to create a video-library of endoscopic cases, patients undergoing screening or
           diagnostic colonoscopy will be considered for inclusion. Patients with at least one
           histologically verified <10 mm polyp will be included. A short video-clip (around 15-20
           seconds) of each polyp both at white-light and FICE-light will be recorded and stored in
           an anonymized database.

        2. Once the video-library is completed, each of 7 experts will independently review all the
           cases. For each case, any observer will assess each of the three NICE criteria
           (colour/vascularization/surface), the degree of confidence (low/high), and classify the
           lesion as neoplastic or non-neoplastic. The primary outcomes are the accuracy of FICE
           technology with high-definition and without magnification, when adopting NICE
           classification, to differentiate between hyperplastic and adenomatous lesions, and the
           inter-observer agreement in such differentiation. Secondary end-points are to assess at
           multivariate measure the role of any individual criteria of NICE classification in the
           discrimination between the two histotypes, and possible adaptations of NICE
           classification in order to be applied with FICE.
observational model: Case-Only
time perspective: Prospective
measure: accuracy of the NICE criteria using FICE technology for differentiating between the non-neoplastic and neoplastic histotypes in diagnoses with high-confidence on a video-library of 110 polyps reviewed by 7 experts.
time frame: up to 6 months
description: 7 experts will review videos from a video-library of subcentimetric polyps removed and histologically verified and will assess each of the three NICE criteria (colour/vascularization/surface), and classify the lesion as neoplastic or non-neoplastic with low or high confidence.
measure: Inter-observer agreement among the 7 experts
time frame: up to 6 months
description: The inter-observer agreement, among the 7 experts, on the final diagnosis (neoplastic or non-neoplastic) and on each individual NICE criterion for each polyp will be determined by using K statistics .
measure: Accuracy of additional criteria, such as the presence of mucus, to differentiate between sub-types of non-neoplastic lesions (i.e. serrated lesions)
time frame: up to 6 month
arm group label: histologically-verified <10mm polyps
description: histologically-verified <10mm polyps, analyzed by virtual chromo-endoscopy using FICE Fujifilm Technology
intervention type: Procedure
intervention name: virtual chromo-endoscopy using FICE Fujifilm Technology
description: For each polyps, any observer will use virtual chromo-endoscopy with FICE Fujifilm Technology
arm group label: histologically-verified <10mm polyps
colonic polyps
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Alessandro Repici, MD
role: Principal Investigator
affiliation: Istituto Clinico Humanitas
last name: Alessandro Repici, MD
phone: +39282247493
email: alessandro.repici@humanitas.it
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Belgium
country: France
country: Germany
country: Italy
country: United Kingdom
citation: Hewett DG, Kaltenbach T, Sano Y, Tanaka S, Saunders BP, Ponchon T, Soetikno R, Rex DK. Validation of a simple classification system for endoscopic diagnosis of small colorectal polyps using narrow-band imaging. Gastroenterology. 2012 Sep;143(3):599-607.e1. doi: 10.1053/j.gastro.2012.05.006. Epub 2012 May 15.
PMID: 22609383
responsible party type: Principal Investigator
investigator affiliation: Istituto Clinico Humanitas
investigator full name: Michele Tedeschi
investigator title: Responsabile Progetto Ricerca Clinica
mesh term: Adenomatous Polyps
mesh term: Polyps