<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/NCT04408703</url>
  </required_header>
  <id_info>
    <org_study_id>s63012</org_study_id>
    <nct_id>NCT04408703</nct_id>
  </id_info>
  <brief_title>PRognOstiC valuE of rEd Density in Ulcerative Colitis</brief_title>
  <acronym>PROCEED-UC</acronym>
  <official_title>PRognOstiC valuE of rEd Density in Ulcerative Colitis: PROCEED-UC STUDY</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sapporo Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Imelda GI Clinical Research Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Observational prospective multicenter study: baseline assessement of the disease activity by&#xD;
      an automated endoscopic tool and follow up of 52 weeks to evaluate sustained clinical&#xD;
      remission.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 2020</start_date>
  <completion_date type="Anticipated">June 2022</completion_date>
  <primary_completion_date type="Anticipated">June 2021</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>sustained clinical remission</measure>
    <time_frame>week 52</time_frame>
    <description>Number of patients with sustained clinical remission at week 52, defined as simple clinical colitis activity index (SCCAI) &lt;3 AND no need for initiation of new treatment, escalation of therapy, UC related hospitalization or colectomy correlated to the RD score at baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>endoscopic remission Mayo</measure>
    <time_frame>week 52</time_frame>
    <description>Number of patients with Mayo endoscopic subscore of 0 after 52 weeks correlated to the RD score at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>endoscopic remission UCEIS</measure>
    <time_frame>week 52</time_frame>
    <description>Number of patients with UCEIS of 0 after 52 weeks correlated to the RD score at baseline.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>correlation biomarker</measure>
    <time_frame>week 52</time_frame>
    <description>Correlation between RD scores and fecal calprotectin, C-reactive protein (CRP), platelet count and haemoglobin at any point in the study.</description>
  </other_outcome>
  <other_outcome>
    <measure>correlation histological score</measure>
    <time_frame>week 52</time_frame>
    <description>Correlation between RD scores and Geboes histological score, the Nancy and the Robarts histological index at any point in the study.</description>
  </other_outcome>
  <other_outcome>
    <measure>correlation endoscopic score</measure>
    <time_frame>week 52</time_frame>
    <description>Correlation between RD scores and Mayo endoscopic subscore and UCEIS at any point in the study.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">243</enrollment>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>Ulcerative colitis in clinical remission</arm_group_label>
    <description>Clinical remission with SCCAI &lt;3 at baseline and stable remission for the last 3 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Red Density</intervention_name>
    <description>Image analysis of endoscopic images in patients with ulcerative colitis</description>
    <arm_group_label>Ulcerative colitis in clinical remission</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum albumin, faecal calprotectin, C-reactive protein, thrombocytosis and haemoglobin&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with ulcerative colitis in clinical remission&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed diagnosis of UC for at least 3 months&#xD;
&#xD;
          -  Clinical remission with SCCAI &lt;3 at baseline and stable remission for the last 3&#xD;
             months&#xD;
&#xD;
          -  Ability to give informed consent by the patient or legal representative in case of&#xD;
             minority.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any contraindication for sigmoidoscopy or undergoing biopsies of the rectosigmoid.&#xD;
&#xD;
          -  Uncontrolled coagulopathy.&#xD;
&#xD;
          -  Any planned change in UC related treatment (both escalation and de-escalation) after&#xD;
             the baseline endoscopy&#xD;
&#xD;
          -  Planned UC related surgery&#xD;
&#xD;
          -  Previous subtotal or total colectomy&#xD;
&#xD;
          -  Short bowel, ileostomy or colostomy&#xD;
&#xD;
          -  Pregnancy at baseline&#xD;
&#xD;
          -  Age younger than 16 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raf Bisschops, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Leuven</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Bossuyt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Leuven</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peter Bossuyt, MD</last_name>
    <phone>+3215505165</phone>
    <email>peter.bossuyt@imelda.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chelsea Camps</last_name>
    <phone>+3216332211</phone>
    <email>chelsea.camps@uzleuven.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Imelda GI clinical research center</name>
      <address>
        <city>Bonheiden</city>
        <zip>2820</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <contact>
      <last_name>Peter Bossuyt, MD</last_name>
      <phone>015505165</phone>
      <email>peter.bossuyt@imelda.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <contact>
      <last_name>Chelsea Camps</last_name>
      <phone>+3216332211</phone>
      <email>chelsea.camps@uzleuven.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Bossuyt P, Nakase H, Vermeire S, de Hertogh G, Eelbode T, Ferrante M, Hasegawa T, Willekens H, Ikemoto Y, Makino T, Bisschops R. Automatic, computer-aided determination of endoscopic and histological inflammation in patients with mild to moderate ulcerative colitis based on red density. Gut. 2020 Oct;69(10):1778-1786. doi: 10.1136/gutjnl-2019-320056. Epub 2020 Jan 8.</citation>
    <PMID>31915237</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 25, 2020</last_update_submitted>
  <last_update_submitted_qc>May 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Endoscopy</keyword>
  <keyword>Artificial intelligence</keyword>
  <keyword>Image analysis</keyword>
  <keyword>Precision medicine</keyword>
  <keyword>Inflammatory bowel disease</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>Undecided</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/NCT04408703
org study id: s63012
nct id: NCT04408703
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Observational prospective multicenter study: baseline assessement of the disease activity by
      an automated endoscopic tool and follow up of 52 weeks to evaluate sustained clinical
      remission.
observational model: Cohort
time perspective: Prospective
measure: sustained clinical remission
time frame: week 52
description: Number of patients with sustained clinical remission at week 52, defined as simple clinical colitis activity index (SCCAI) <3 AND no need for initiation of new treatment, escalation of therapy, UC related hospitalization or colectomy correlated to the RD score at baseline.
measure: endoscopic remission Mayo
time frame: week 52
description: Number of patients with Mayo endoscopic subscore of 0 after 52 weeks correlated to the RD score at baseline.
measure: endoscopic remission UCEIS
time frame: week 52
description: Number of patients with UCEIS of 0 after 52 weeks correlated to the RD score at baseline.
measure: correlation biomarker
time frame: week 52
description: Correlation between RD scores and fecal calprotectin, C-reactive protein (CRP), platelet count and haemoglobin at any point in the study.
measure: correlation histological score
time frame: week 52
description: Correlation between RD scores and Geboes histological score, the Nancy and the Robarts histological index at any point in the study.
measure: correlation endoscopic score
time frame: week 52
description: Correlation between RD scores and Mayo endoscopic subscore and UCEIS at any point in the study.
arm group label: Ulcerative colitis in clinical remission
description: Clinical remission with SCCAI <3 at baseline and stable remission for the last 3 months
intervention type: Diagnostic Test
intervention name: Red Density
description: Image analysis of endoscopic images in patients with ulcerative colitis
arm group label: Ulcerative colitis in clinical remission
serum albumin, faecal calprotectin, C-reactive protein, thrombocytosis and haemoglobin
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Raf Bisschops, MD PhD
role: Principal Investigator
affiliation: UZ Leuven
last name: Peter Bossuyt, MD
role: Principal Investigator
affiliation: UZ Leuven
last name: Peter Bossuyt, MD
phone: +3215505165
email: peter.bossuyt@imelda.be
last name: Chelsea Camps
phone: +3216332211
email: chelsea.camps@uzleuven.be
facility: 
contact: 
facility: 
contact: 
country: Belgium
citation: Bossuyt P, Nakase H, Vermeire S, de Hertogh G, Eelbode T, Ferrante M, Hasegawa T, Willekens H, Ikemoto Y, Makino T, Bisschops R. Automatic, computer-aided determination of endoscopic and histological inflammation in patients with mild to moderate ulcerative colitis based on red density. Gut. 2020 Oct;69(10):1778-1786. doi: 10.1136/gutjnl-2019-320056. Epub 2020 Jan 8.
PMID: 31915237
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
sharing ipd: Undecided