<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/NCT01663142</url>
  </required_header>
  <id_info>
    <org_study_id>09-API-02</org_study_id>
    <nct_id>NCT01663142</nct_id>
  </id_info>
  <brief_title>Early Postoperative Recurrence in Crohn's Disease: Predictors of Research Targeting the Constitutional Mutation of IRGM</brief_title>
  <official_title>Early Postoperative Recurrence in Crohn's Disease: Predictors of Research Targeting the Constitutional Mutation of IRGM</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nice</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Crohn's disease is a disease of complex etiology, multifactorial and still poorly understood.&#xD;
      This disease, due to its morbidity and mortality, poses a significant public health problem&#xD;
      in France. Apart from the involvement of bacterial factors and those involving the&#xD;
      permeability of the epithelial barrier, it is now well recognized that several factors are&#xD;
      associated with genetic predisposition in some of these patients. Among these factors, the&#xD;
      Nod2 mutations were first identified. Studies concerning the presence of these mutations and&#xD;
      the severity of disease results were sometimes conflicting. Very recently, new interesting&#xD;
      mutations in genes involved in autophagy were found with greater frequency in patients with&#xD;
      Crohn's disease. These mutations observed in Atg16 and IRGM genes. It has been particularly&#xD;
      shown on large patient cohorts,the IRGM polymorphism was associated with a progressive&#xD;
      disease, with histological severity scores. One of the severity criteria of Crohn's disease&#xD;
      is the early recurrence observed in some patients after surgical resection of the injured&#xD;
      segment. Predictive factors for such recurrence after surgery are not known or not.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2010</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Actual">October 2013</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>Search for IRGM mutations and compare the frequency of these mutations.</measure>
    <description>Patients who receive surgical resection for intestinal MC have, within six months after surgery gastrointestinal endoscopy for judging the endoscopic recurrence and modify treatment if necessary. This quantifies the endoscopic recurrence of i0 to i4 classified according to the Rutgeerts score (45). Patients who have a score ≥ i2 have a severe endoscopic recurrence. We will compare the prevalence of sick with a score ≥ i2 in patient groups with or without mutation in the gene IRGM. The investigators will look for the existence of a mutation in the gene IRGM, Atg16 and IL23R. The mutation in the gene IRGM being the main prognostic factor, mutations in the genes IL23R Atg16 and prognostic factors constituting secondary.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To assess the prevalence of mutations IGRM in a prospective series of 200 patients operated</measure>
    <description>The prevalence of mutations IGRM, Atg16 and IL23 will be determined</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine whether there are phenotypic characteristics of the disease associated with mutations of IGRM</measure>
    <description>The investigators will compare the frequency of postoperative recurrence in patients who have a mutation in the genes IL23 and Atg16</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine whether there are pathological features associated with mutations of IGRM.</measure>
    <description>The investigators will determine if the main phenotypic characteristics of CD (age of onset, time between diagnosis and surgery, use of immunosuppressive and biologic therapies, smoking localization of the disease, etc..) Are associated with increased prevalence of mutations of IGRM, Atg16 and IL23R.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Flammatory Bowel Disease</condition>
  <condition>Crohn's Disease</condition>
  <arm_group>
    <arm_group_label>Patients who receive surgical resection for intestinal in CD</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Lesional tissue samples and healthy in cryotubes, taken from surgical specimens or biopsies.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Sick to benefit from ileal, colonic or ileocolic continuity with re Cohn proved a&#xD;
        complicated disease (stenosis or fistula) or resistant to medical treatment well led&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sick in whom endoscopic control six months after surgery is needed to assess the&#xD;
             presence and severity of endoscopic recurrence in order to alter the medical&#xD;
             management.&#xD;
&#xD;
          -  Persons affiliated to the Social Security&#xD;
&#xD;
          -  Persons who have signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient not affiliated to social security&#xD;
&#xD;
          -  Pregnant Women&#xD;
&#xD;
          -  Persons participating in other clinical trials&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xavier HEBUTERNE, PU-PH</last_name>
    <role>Study Director</role>
    <affiliation>Centre Hospitalier Universitaire de Nice</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xavier HEBUTERNE, PU-PH</last_name>
    <email>hebuterne.x@chu-nice.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cassandre LANDES, Ingenior</last_name>
    <phone>0492034126</phone>
    <phone_ext>+33</phone_ext>
    <email>landes.c@chu-nice.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU de Grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bruno BONAZ, PU-PH</last_name>
    </contact>
    <investigator>
      <last_name>Bruno BONAZ, PU-PH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>AP-HM</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michel VEYRAC, PH</last_name>
    </contact>
    <investigator>
      <last_name>Michel VEYRAC, PH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Nice</name>
      <address>
        <city>Nice</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xavier HEBUTERNE, PU-PH</last_name>
      <email>hebuterne.x@chu-nice.fr</email>
    </contact>
    <investigator>
      <last_name>Xavier HEBUTERNE, PU-PH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2010</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>October 30, 2015</last_update_submitted>
  <last_update_submitted_qc>October 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Crohn's disease</keyword>
  <keyword>gastrointestinal tract</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Recurrence</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/NCT01663142
org study id: 09-API-02
nct id: NCT01663142
lead sponsor: 
has dmc: No
Crohn's disease is a disease of complex etiology, multifactorial and still poorly understood.
      This disease, due to its morbidity and mortality, poses a significant public health problem
      in France. Apart from the involvement of bacterial factors and those involving the
      permeability of the epithelial barrier, it is now well recognized that several factors are
      associated with genetic predisposition in some of these patients. Among these factors, the
      Nod2 mutations were first identified. Studies concerning the presence of these mutations and
      the severity of disease results were sometimes conflicting. Very recently, new interesting
      mutations in genes involved in autophagy were found with greater frequency in patients with
      Crohn's disease. These mutations observed in Atg16 and IRGM genes. It has been particularly
      shown on large patient cohorts,the IRGM polymorphism was associated with a progressive
      disease, with histological severity scores. One of the severity criteria of Crohn's disease
      is the early recurrence observed in some patients after surgical resection of the injured
      segment. Predictive factors for such recurrence after surgery are not known or not.
observational model: Cohort
time perspective: Prospective
measure: Search for IRGM mutations and compare the frequency of these mutations.
description: Patients who receive surgical resection for intestinal MC have, within six months after surgery gastrointestinal endoscopy for judging the endoscopic recurrence and modify treatment if necessary. This quantifies the endoscopic recurrence of i0 to i4 classified according to the Rutgeerts score (45). Patients who have a score ≥ i2 have a severe endoscopic recurrence. We will compare the prevalence of sick with a score ≥ i2 in patient groups with or without mutation in the gene IRGM. The investigators will look for the existence of a mutation in the gene IRGM, Atg16 and IL23R. The mutation in the gene IRGM being the main prognostic factor, mutations in the genes IL23R Atg16 and prognostic factors constituting secondary.
measure: To assess the prevalence of mutations IGRM in a prospective series of 200 patients operated
description: The prevalence of mutations IGRM, Atg16 and IL23 will be determined
measure: Determine whether there are phenotypic characteristics of the disease associated with mutations of IGRM
description: The investigators will compare the frequency of postoperative recurrence in patients who have a mutation in the genes IL23 and Atg16
measure: Determine whether there are pathological features associated with mutations of IGRM.
description: The investigators will determine if the main phenotypic characteristics of CD (age of onset, time between diagnosis and surgery, use of immunosuppressive and biologic therapies, smoking localization of the disease, etc..) Are associated with increased prevalence of mutations of IGRM, Atg16 and IL23R.
arm group label: Patients who receive surgical resection for intestinal in CD
Lesional tissue samples and healthy in cryotubes, taken from surgical specimens or biopsies.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xavier HEBUTERNE, PU-PH
role: Study Director
affiliation: Centre Hospitalier Universitaire de Nice
last name: Xavier HEBUTERNE, PU-PH
email: hebuterne.x@chu-nice.fr
last name: Cassandre LANDES, Ingenior
phone: 0492034126
phone ext: +33
email: landes.c@chu-nice.fr
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Crohn Disease
mesh term: Recurrence