<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/NCT03751722</url>
  </required_header>
  <id_info>
    <org_study_id>2005/0528</org_study_id>
    <secondary_id>DGS 2006/0083</secondary_id>
    <nct_id>NCT03751722</nct_id>
  </id_info>
  <brief_title>Genetic an Functional Studies of Patient With Inflammatory Bowel Disease</brief_title>
  <acronym>MINOTOR</acronym>
  <official_title>Genetic an Functional Studies of Patient With Inflammatory Bowel Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to study the response of macrophages, isolated from patients&#xD;
      with ulcerative colitis (Crohn's disease) or Crohn's disease (CD), to 6 candidate&#xD;
      enterogenous and their derivatives, depending on the genotype for associated polymorphisms.&#xD;
      to the development of IBD&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2007</start_date>
  <completion_date type="Actual">April 10, 2017</completion_date>
  <primary_completion_date type="Actual">April 10, 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>Isolated macrophage response measured by PCR</measure>
    <time_frame>Baseline: one session</time_frame>
    <description>identification of macrophage activation markers specific analysis of gene expression (by PCR in real time) and / or the production (ELISA) of proinflammatory molecules (IL-6, TNF-1 and IL-8), anti-inflammatory (IL-10) and immunomodulatory (IL4,PPAR -2, MOR)</description>
  </primary_outcome>
  <enrollment type="Actual">630</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All outpatients and inpatients from gastroenterology units of adulte and pediatric&#xD;
        references centers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient with definite crohn's disease or ulcerative colitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient receiving anti-TNF therapy during 14 days before inclusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Corinne Gower-Rousseau, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHRU, Hôpital Claude Huriez</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Crohn disease</keyword>
  <keyword>Ulcerative colitis</keyword>
  <keyword>genetic makers</keyword>
  <keyword>cytokines</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</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/NCT03751722
org study id: 2005/0528
secondary id: DGS 2006/0083
nct id: NCT03751722
lead sponsor: 
has dmc: No
The objective of this study is to study the response of macrophages, isolated from patients
      with ulcerative colitis (Crohn's disease) or Crohn's disease (CD), to 6 candidate
      enterogenous and their derivatives, depending on the genotype for associated polymorphisms.
      to the development of IBD
observational model: Cohort
time perspective: Prospective
measure: Isolated macrophage response measured by PCR
time frame: Baseline: one session
description: identification of macrophage activation markers specific analysis of gene expression (by PCR in real time) and / or the production (ELISA) of proinflammatory molecules (IL-6, TNF-1 and IL-8), anti-inflammatory (IL-10) and immunomodulatory (IL4,PPAR -2, MOR)
blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: N/A
healthy volunteers: No
last name: Corinne Gower-Rousseau, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
country: France
responsible party type: Sponsor
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
sharing ipd: No