<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/NCT03824418</url>
  </required_header>
  <id_info>
    <org_study_id>00001</org_study_id>
    <nct_id>NCT03824418</nct_id>
  </id_info>
  <brief_title>The Clinical Value of Chromoendoscopy as Surveillance Strategy for Dysplasia Detection in Ulcerative Colitis</brief_title>
  <official_title>The Clinical Value of Chromoendoscopy as Surveillance Strategy for Dysplasia Detection in Ulcerative Colitis: an Observational Follow-up Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</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>
      A recent multicentre randomised controlled trial compared autofluorescence imaging (AFI) with&#xD;
      CE for dysplasia detection in colonoscopy surveillance of patients with longstanding UC&#xD;
      (FIND-UC). In this study, CE detected significantly more dysplastic lesions per patient&#xD;
      compared with AFI. It is unclear whether this increased dysplasia detection also translates&#xD;
      to a reduction of dysplasia at follow-up colonoscopy. The aim of this pre-specified study is&#xD;
      therefore to prospectively determine whether there is a difference in dysplasia detection at&#xD;
      follow-up colonoscopy between UC patients who were randomized to AFI or CE at index&#xD;
      colonoscopy for the FIND-UC trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 9, 2016</start_date>
  <completion_date type="Actual">October 1, 2018</completion_date>
  <primary_completion_date type="Actual">May 9, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>the proportion of patients in which at least one histological proven dysplastic lesions was detected at follow-up colonoscopy.</measure>
    <time_frame>during surveillance colonoscopy</time_frame>
    <description>the proportion of patients in which at least one histological proven dysplastic lesions was detected at follow-up colonoscopy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients in which at least one histological proven neoplastic lesion was detected</measure>
    <time_frame>during surveillance colonoscopy</time_frame>
    <description>The proportion of patients in which at least one histological proven neoplastic lesion was detected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The mean number of histological proven neoplastic lesions per patient</measure>
    <time_frame>during surveillance colonoscopy</time_frame>
    <description>The mean number of histological proven neoplastic lesions per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients in which at least one histological proven sessile serrated lesion was detected</measure>
    <time_frame>during surveillance colonoscopy</time_frame>
    <description>The proportion of patients in which at least one histological proven sessile serrated lesion was detected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The mean number of histological proven sessile serrated lesions per patient</measure>
    <time_frame>during surveillance colonoscopy</time_frame>
    <description>The mean number of histological proven sessile serrated lesions per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of dysplasia detected at follow-up colonoscopy (colonic segment, location with respect to a resection scar if visible), or in the resection specimen after proctocolectomy. The proportion of lesions defined as new/missed and recurrent lesion</measure>
    <time_frame>during surveillance colonoscopy</time_frame>
    <description>Description of dysplasia detected at follow-up colonoscopy (colonic segment, location with respect to a resection scar if visible), or in the resection specimen after proctocolectomy. The proportion of lesions defined as new/missed and recurrent lesions detected during surveillance colonoscopy.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">210</enrollment>
  <condition>Ulcerative Colitis</condition>
  <condition>Chromoendoscopy</condition>
  <arm_group>
    <arm_group_label>Chromoendoscopy follow-up</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Autofluorescence follow-up</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surveillance colonoscopy with chromoendoscopy</intervention_name>
    <description>Surveillance colonoscopy with chromoendoscopy</description>
    <arm_group_label>Autofluorescence follow-up</arm_group_label>
    <arm_group_label>Chromoendoscopy follow-up</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients of the FIND-UC trial that undergo a follow surveillance colonoscopy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Patients are eligible for inclusion in this study when they meet the following criteria:&#xD;
&#xD;
        Inclusion criteria&#xD;
&#xD;
        In order to be eligible to participate in this study, a subject must meet all of the&#xD;
        following criteria:&#xD;
&#xD;
        - Patients that where included in the previous FIND-UC trial&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
        A potential subject who meets any of the following criteria will be excluded from&#xD;
        participation in this study:&#xD;
&#xD;
          -  Patients who not receive their surveillance colonoscopy with CE&#xD;
&#xD;
          -  Patients who not undergo their surveillance colonoscopy within 3 months of the&#xD;
             surveillance recommendations&#xD;
&#xD;
        Withdrawal of individual subjects&#xD;
&#xD;
        A patient will be excluded from the study if any of the following events occur:&#xD;
&#xD;
          -  Withdrawal of informed consent&#xD;
&#xD;
          -  The patient requests to be discontinued from the study&#xD;
&#xD;
          -  The bowel preparation is scored as Boston Bowel Preparation Scale &lt;6&#xD;
&#xD;
          -  Incomplete colonoscopy because the endoscopist is unable to intubate the cecum during&#xD;
             the colonoscopy&#xD;
&#xD;
          -  The Mayo-score &gt; 1 in at least in one of the bowel segments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Academic Medical Centre</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord-Holland</state>
        <zip>1105AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>March 9, 2018</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>Prof. Evelien Dekker, MD, PhD</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Surveillance</keyword>
  <keyword>Chromoendoscopy</keyword>
  <keyword>Dysplasia</keyword>
  <keyword>Ulcerative Colitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
  </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/NCT03824418
org study id: 00001
nct id: NCT03824418
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A recent multicentre randomised controlled trial compared autofluorescence imaging (AFI) with
      CE for dysplasia detection in colonoscopy surveillance of patients with longstanding UC
      (FIND-UC). In this study, CE detected significantly more dysplastic lesions per patient
      compared with AFI. It is unclear whether this increased dysplasia detection also translates
      to a reduction of dysplasia at follow-up colonoscopy. The aim of this pre-specified study is
      therefore to prospectively determine whether there is a difference in dysplasia detection at
      follow-up colonoscopy between UC patients who were randomized to AFI or CE at index
      colonoscopy for the FIND-UC trial.
observational model: Cohort
time perspective: Prospective
measure: the proportion of patients in which at least one histological proven dysplastic lesions was detected at follow-up colonoscopy.
time frame: during surveillance colonoscopy
description: the proportion of patients in which at least one histological proven dysplastic lesions was detected at follow-up colonoscopy.
measure: The proportion of patients in which at least one histological proven neoplastic lesion was detected
time frame: during surveillance colonoscopy
description: The proportion of patients in which at least one histological proven neoplastic lesion was detected
measure: The mean number of histological proven neoplastic lesions per patient
time frame: during surveillance colonoscopy
description: The mean number of histological proven neoplastic lesions per patient
measure: The proportion of patients in which at least one histological proven sessile serrated lesion was detected
time frame: during surveillance colonoscopy
description: The proportion of patients in which at least one histological proven sessile serrated lesion was detected
measure: The mean number of histological proven sessile serrated lesions per patient
time frame: during surveillance colonoscopy
description: The mean number of histological proven sessile serrated lesions per patient
measure: Description of dysplasia detected at follow-up colonoscopy (colonic segment, location with respect to a resection scar if visible), or in the resection specimen after proctocolectomy. The proportion of lesions defined as new/missed and recurrent lesion
time frame: during surveillance colonoscopy
description: Description of dysplasia detected at follow-up colonoscopy (colonic segment, location with respect to a resection scar if visible), or in the resection specimen after proctocolectomy. The proportion of lesions defined as new/missed and recurrent lesions detected during surveillance colonoscopy.
arm group label: Chromoendoscopy follow-up
arm group label: Autofluorescence follow-up
intervention type: Procedure
intervention name: Surveillance colonoscopy with chromoendoscopy
description: Surveillance colonoscopy with chromoendoscopy
arm group label: Autofluorescence follow-up
arm group label: Chromoendoscopy follow-up
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: Prof. Evelien Dekker, MD, PhD
investigator title: Clinical Professor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
sharing ipd: Yes
ipd info type: Study Protocol