<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/NCT03809728</url>
  </required_header>
  <id_info>
    <org_study_id>PSS 2018 / I-BANK-GERMAIN / MS</org_study_id>
    <nct_id>NCT03809728</nct_id>
  </id_info>
  <brief_title>IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS IN INFLAMMATORY BOWEL DISEASE</brief_title>
  <acronym>i-BANK</acronym>
  <official_title>IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS OF NATURAL HISTORY AND RESPONSE TO BIOTHERAPIES IN INFLAMMATORY BOWEL DISEASE : i-BANK</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</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>
      Interventional study of a group of patients with an inflammatory bowel disease (Crohn's&#xD;
      disease or ulcerative colitis) to identify predictive and prognostic biomarkers of natural&#xD;
      history and response to biotherapies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Percentage of primary responders who haven't lost response to biotherapies during follow-up&#xD;
      (anti-TNF, ustekinumab, vedolizumab).&#xD;
&#xD;
      Response to treatment will be evaluated using objective criteria for measuring intestinal&#xD;
      inflammation: endoscopic remission (endoscopic biopsy and surgical specimens), radiological&#xD;
      (MRI), and / or biological (CRP, fecal calprotectin) .&#xD;
&#xD;
      Response to therapy rates will be correlated with genomic, epigenomic, and microbiota data&#xD;
      stratified by major environmental factors (nutrition, tobacco, physical activity).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 10, 2019</start_date>
  <completion_date type="Anticipated">April 2, 2029</completion_date>
  <primary_completion_date type="Anticipated">December 10, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients who have lost response to biotherapies (anti-TNF, ustekinumab, vedolizumab).</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who underwent surgery</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative morbidity rates in IBD</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical recurrent rate in Crohn's disease</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Propotion of patients with a destruction of the intestinal wall in CD (abscess, fistula)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients developing a cancer</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission rates for acute severe colitis or ileitis</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <condition>Crohn Disease</condition>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>IBD patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All patients with an established Crohn's disease or ulcerative colitis</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>endoscopic biopsy</intervention_name>
    <description>Per-endoscopic biopsies</description>
    <arm_group_label>IBD patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>samples of the oral cavity</intervention_name>
    <description>7 samples of the oral cavity with a swab</description>
    <arm_group_label>IBD patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Samples of the resected specimen</intervention_name>
    <description>if patient has to undergo a digestive resection as part of his standard management, samples of the pathological area and samples at the end of the resection will be realised</description>
    <arm_group_label>IBD patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt;=18 years&#xD;
&#xD;
          -  Patients with an established diagnosis of CD or UC (clinical, biological,&#xD;
             radiological, endoscopic or histologic criteria)&#xD;
&#xD;
          -  Patients &gt;=45 kg&#xD;
&#xD;
          -  Affiliated member of the Social Security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with an undetermined colitis&#xD;
&#xD;
          -  Patients with a non established diagnosis of CD&#xD;
&#xD;
          -  Women of childbearing age without a method of contraception&#xD;
&#xD;
          -  Persons covered by articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code&#xD;
&#xD;
          -  Pregnant women, breastfeeding women&#xD;
&#xD;
             -- Age &lt; 18 years&#xD;
&#xD;
          -  Persons under legal protection&#xD;
&#xD;
          -  Person who does not have the capacity to consent&#xD;
&#xD;
          -  Persons under the age of 18 years who are deprived of their liberty by decision of a&#xD;
             judicial or administrative authority (articles L. 3212-1 and L. 3213-1).&#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>Adeline GERMAIN, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHRU Nancy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Adeline GERMAIN, MD, PhD</last_name>
    <phone>+33383153120</phone>
    <email>a.germain@chru-nancy.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHRU Nancy</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <zip>54510</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marjorie STARCK</last_name>
      <phone>+33383155273</phone>
      <email>m.starck@chru-nancy.fr</email>
    </contact>
    <investigator>
      <last_name>Laurent PEYRIN-BIROULET, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Adeline GERMAIN, MD,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Laurent BRESLER, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Camille ZALLOT, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marine FERRY, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>February 8, 2023</last_update_submitted>
  <last_update_submitted_qc>February 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Central Hospital, Nancy, France</investigator_affiliation>
    <investigator_full_name>Dr Laurent PEYRIN-BIROULET</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</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/NCT03809728
org study id: PSS 2018 / I-BANK-GERMAIN / MS
nct id: NCT03809728
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Interventional study of a group of patients with an inflammatory bowel disease (Crohn's
      disease or ulcerative colitis) to identify predictive and prognostic biomarkers of natural
      history and response to biotherapies.
Percentage of primary responders who haven't lost response to biotherapies during follow-up
      (anti-TNF, ustekinumab, vedolizumab).

      Response to treatment will be evaluated using objective criteria for measuring intestinal
      inflammation: endoscopic remission (endoscopic biopsy and surgical specimens), radiological
      (MRI), and / or biological (CRP, fecal calprotectin) .

      Response to therapy rates will be correlated with genomic, epigenomic, and microbiota data
      stratified by major environmental factors (nutrition, tobacco, physical activity).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of patients who have lost response to biotherapies (anti-TNF, ustekinumab, vedolizumab).
time frame: 5 years
measure: Proportion of patients who underwent surgery
time frame: 5 years
measure: Post-operative morbidity rates in IBD
time frame: 5 years
measure: Surgical recurrent rate in Crohn's disease
time frame: 5 years
measure: Propotion of patients with a destruction of the intestinal wall in CD (abscess, fistula)
time frame: 5 years
measure: Proportion of patients developing a cancer
time frame: 5 years
measure: Readmission rates for acute severe colitis or ileitis
time frame: 5 years
arm group label: IBD patients
arm group type: Other
description: All patients with an established Crohn's disease or ulcerative colitis
intervention type: Procedure
intervention name: endoscopic biopsy
description: Per-endoscopic biopsies
arm group label: IBD patients
intervention type: Procedure
intervention name: samples of the oral cavity
description: 7 samples of the oral cavity with a swab
arm group label: IBD patients
intervention type: Procedure
intervention name: Samples of the resected specimen
description: if patient has to undergo a digestive resection as part of his standard management, samples of the pathological area and samples at the end of the resection will be realised
arm group label: IBD patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Adeline GERMAIN, MD, PhD
role: Principal Investigator
affiliation: CHRU Nancy
last name: Adeline GERMAIN, MD, PhD
phone: +33383153120
email: a.germain@chru-nancy.fr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Central Hospital, Nancy, France
investigator full name: Dr Laurent PEYRIN-BIROULET
investigator title: Doctor
mesh term: Crohn Disease
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
sharing ipd: Undecided