<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/NCT03272152</url>
  </required_header>
  <id_info>
    <org_study_id>20170808</org_study_id>
    <nct_id>NCT03272152</nct_id>
  </id_info>
  <brief_title>Comprehensive DNA Methylation Profiling in Crohn's Disease</brief_title>
  <official_title>Comprehensive DNA Methylation Profiling of Inflammatory and Non-Inflammatory Mucosa in Crohn's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jinling Hospital, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jinling Hospital, China</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Previous studies have indicated that abnormal DNA methylation frequently occurs in the mucosa&#xD;
      in Crohn's disease. Comprehensive DNA methylation profiling of the inflamed and non-inflamed&#xD;
      ileal mucosa of patients with Crohn's disease was performed. Genome-wide DNA methylation was&#xD;
      determined using the Illumina HumanMethylation 850k BeadChip.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">September 30, 2017</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>Intestinal inflammation under colonoscopy</measure>
    <time_frame>Jan 2017 to Sep 2017</time_frame>
    <description>Intestinal ulcer or enteritisis observed under colonoscopy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CDAI</measure>
    <time_frame>Jan 2017 to Sep 2017</time_frame>
    <description>Crohns Disease Activity Index is measured.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">14</enrollment>
  <condition>Crohn Disease</condition>
  <condition>Methylation</condition>
  <condition>Illumina Human Methylation 850k BeadChip</condition>
  <arm_group>
    <arm_group_label>Inflamed CD group</arm_group_label>
    <description>Inflamed ileal mucosa was obtained from inflammed lesions of active CD patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-inflamed CD group</arm_group_label>
    <description>Non-inflamed ileal mucosa was obtained from normal sites of active CD patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Control ileal mucosa was obtained from healthy patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Genome-wide DNA methylation</intervention_name>
    <description>Genome-wide DNA methylation was determined using the Infinium Human Methylation 850K BeadChip.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Inflamed CD group</arm_group_label>
    <arm_group_label>Non-inflamed CD group</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      inflamed and non-inflamed ileal mucosa of patients with Crohn's disease and normal ileal&#xD;
      mucosa of healthy controls&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with active Crohn's disease who underwent colonoscopy at Jinling Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Active Crohn's disease(CDAI score≥ 150)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No ileal lesions&#xD;
&#xD;
          -  Under treatment of immunomodulators, biologic agents or steroids&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jinling Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210002</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianan Ren, MD, PhD</last_name>
      <email>jiananr@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Yuan Li, MD</last_name>
      <email>liyuan9006@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jinling Hospital, China</investigator_affiliation>
    <investigator_full_name>Jianan Ren</investigator_full_name>
    <investigator_title>Director of General Surgery Institute</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</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/NCT03272152
org study id: 20170808
nct id: NCT03272152
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Previous studies have indicated that abnormal DNA methylation frequently occurs in the mucosa
      in Crohn's disease. Comprehensive DNA methylation profiling of the inflamed and non-inflamed
      ileal mucosa of patients with Crohn's disease was performed. Genome-wide DNA methylation was
      determined using the Illumina HumanMethylation 850k BeadChip.
observational model: Case-Control
time perspective: Prospective
measure: Intestinal inflammation under colonoscopy
time frame: Jan 2017 to Sep 2017
description: Intestinal ulcer or enteritisis observed under colonoscopy
measure: CDAI
time frame: Jan 2017 to Sep 2017
description: Crohns Disease Activity Index is measured.
arm group label: Inflamed CD group
description: Inflamed ileal mucosa was obtained from inflammed lesions of active CD patients
arm group label: Non-inflamed CD group
description: Non-inflamed ileal mucosa was obtained from normal sites of active CD patients
arm group label: Control group
description: Control ileal mucosa was obtained from healthy patients
intervention type: Genetic
intervention name: Genome-wide DNA methylation
description: Genome-wide DNA methylation was determined using the Infinium Human Methylation 850K BeadChip.
arm group label: Control group
arm group label: Inflamed CD group
arm group label: Non-inflamed CD group
inflamed and non-inflamed ileal mucosa of patients with Crohn's disease and normal ileal
      mucosa of healthy controls
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Jinling Hospital, China
investigator full name: Jianan Ren
investigator title: Director of General Surgery Institute
mesh term: Crohn Disease