xml: <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/NCT06042387</url>
    </required_header>
    <id_info>
      <org_study_id>02-0234-E</org_study_id>
      <secondary_id>U01DK062423</secondary_id>
      <nct_id>NCT06042387</nct_id>
    </id_info>
    <brief_title>Diverse Ancestry Study in IBD</brief_title>
    <official_title>Diverse Ancestry Study in Inflammatory Bowel Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mount Sinai Hospital, Canada</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Mount Sinai Hospital, Canada</source>
    <oversight_info>
      <has_dmc>No</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>
        Objective:&#xD;
  &#xD;
        To use clinical, genetic and genome analysis to better understand and define the genetic and&#xD;
        environmental factors that contribute to IBD in diverse ancestries:&#xD;
  &#xD;
        African, African American, Black, Afro-Caribbean, Afro-Latino/a/x, Latino/a/x, Hispanic, or&#xD;
        any other Black or Latin or indigenous ancestry.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background:&#xD;
  &#xD;
        Inflammatory bowel disease (IBD) is a chronic, and often disabling, disorder of the&#xD;
        intestines characterized by dysregulation of mucosal immune response. Recent data suggests&#xD;
        that the incidence and prevalence rates among diverse populations may be increasing due to&#xD;
        constantly changing environmental exposures. The goal of the study is to identify susceptible&#xD;
        genes that contribute to the pathogenesis of IBD in individuals who self-identify as African,&#xD;
        African American, Black, Afro-Caribbean, Afro-Latino/a/x, Latino/a/x, Hispanic, or any other&#xD;
        Black or Latin or indigenous ancestry.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2022</start_date>
    <completion_date type="Anticipated">September 2027</completion_date>
    <primary_completion_date type="Anticipated">May 2027</primary_completion_date>
    <study_type>Observational</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>
    <primary_outcome>
      <measure>Genetics studies in diverse ancestries</measure>
      <time_frame>2022-2027</time_frame>
      <description>Whole Exome Sequencing (+/- other sequencing) is planned to assess genetic diversity in diverse populations.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Ulcerative Colitis</condition>
    <condition>Healthy</condition>
    <condition>Crohn Disease</condition>
    <condition>Inflammatory Bowel Diseases</condition>
    <arm_group>
      <arm_group_label>IBD Subjects</arm_group_label>
      <description>Self-identify as:&#xD;
  Black, African, African American, Afro-Caribbean, Afro-Latino/a/x, or Hispanic/Latinx, Afro-Latino/a/x or any other Black or Latin or Indigenous ancestry&#xD;
  Available medical records to confirm IBD diagnosis (Crohn's disease, Ulcerative colitis, IBD undetermined (IBD-U)) Any age</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Controls</arm_group_label>
      <description>Self-identify as:&#xD;
  Black, African, African American, Afro-Caribbean, Afro-Latino/a/x, or Hispanic/Latinx, Afro-Latino/a/x or any other Black or Latin or Indigenous ancestry No personal history of IBD, no family history of IBD, no history of unexplained chronic diarrhea/blood in stool/anemia/abdominal pain/weight loss Any age</description>
    </arm_group>
    <intervention>
      <intervention_type>Genetic</intervention_type>
      <intervention_name>Blood or saliva sample collection</intervention_name>
      <description>Blood or saliva sample &amp; clinical data collection</description>
      <arm_group_label>Controls</arm_group_label>
      <arm_group_label>IBD Subjects</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Participation involves:&#xD;
  &#xD;
        One-time blood (preferred) or saliva sample Collection of clinical data&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          IBD or Healthy controls who self-identify as African, African American, Black,&#xD;
          Afro-Caribbean, Afro-Latino/a/x, Latino/a/x, Hispanic, or any other Black or Latin or&#xD;
          indigenous ancestry&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subject must self-identify as African, African American, Black, Afro-Caribbean,&#xD;
               Afro-Latino/a/x, Latino/a/x, Hispanic, or any other Black or Latin or indigenous&#xD;
               ancestry&#xD;
  &#xD;
            -  Subjects: diagnosed with Inflammatory Bowel Disease (Crohn's disease, ulcerative&#xD;
               colitis, IBD-undetermined)&#xD;
  &#xD;
            -  Available medical records to confirm IBD diagnosis (Crohn's disease, Ulcerative&#xD;
               colitis, IBD undetermined (IBD-U))&#xD;
  &#xD;
            -  Healthy controls: no personal history of IBD, no family history of IBD, no history of&#xD;
               unexplained chronic diarrhea/blood in stool/anemia/abdominal pain/weight loss&#xD;
  &#xD;
            -  Any age&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Doesn't self-identify as African, African American, Black, Afro-Caribbean,&#xD;
               Afro-Latino/a/x, Latino/a/x, Hispanic, or any other Black or Latin or indigenous&#xD;
               ancestry&#xD;
  &#xD;
            -  Subjects with other gastrointestinal conditions not meeting the above IBD or Healthy&#xD;
               Control criteria&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mark Silverberg, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sinai Health System</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Joanne Stempak, MSc</last_name>
      <phone>4165864800</phone>
      <phone_ext>8399</phone_ext>
      <email>joanne.stempak@sinaihealth.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jenny Lee, MKin</last_name>
      <phone>416-586-4800</phone>
      <phone_ext>2318</phone_ext>
      <email>jenny.lee2@sinaihealth.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sinai Health System</name>
        <address>
          <city>Toronto</city>
          <state>Ontario</state>
          <zip>M5G 1X5</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Joanne Stempak, MSc</last_name>
        <phone>4165864800</phone>
        <phone_ext>8399</phone_ext>
        <email>joanne.stempak@sinaihealth.ca</email>
      </contact>
      <contact_backup>
        <last_name>Jenny Lee, MKin</last_name>
        <phone>4165864800</phone>
        <phone_ext>2318</phone_ext>
        <email>IBD.research@sinaihealth.ca</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>May 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mount Sinai Hospital, Canada</investigator_affiliation>
      <investigator_full_name>Mark Silverberg</investigator_full_name>
      <investigator_title>Dr.</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>
  
  
text: 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/NCT06042387
  org study id: 02-0234-E
  secondary id: U01DK062423
  nct id: NCT06042387
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Objective:
  
        To use clinical, genetic and genome analysis to better understand and define the genetic and
        environmental factors that contribute to IBD in diverse ancestries:
  
        African, African American, Black, Afro-Caribbean, Afro-Latino/a/x, Latino/a/x, Hispanic, or
        any other Black or Latin or indigenous ancestry.
  Background:
  
        Inflammatory bowel disease (IBD) is a chronic, and often disabling, disorder of the
        intestines characterized by dysregulation of mucosal immune response. Recent data suggests
        that the incidence and prevalence rates among diverse populations may be increasing due to
        constantly changing environmental exposures. The goal of the study is to identify susceptible
        genes that contribute to the pathogenesis of IBD in individuals who self-identify as African,
        African American, Black, Afro-Caribbean, Afro-Latino/a/x, Latino/a/x, Hispanic, or any other
        Black or Latin or indigenous ancestry.
  observational model: Case-Control
  time perspective: Prospective
  measure: Genetics studies in diverse ancestries
  time frame: 2022-2027
  description: Whole Exome Sequencing (+/- other sequencing) is planned to assess genetic diversity in diverse populations.
  arm group label: IBD Subjects
  description: Self-identify as:
  Black, African, African American, Afro-Caribbean, Afro-Latino/a/x, or Hispanic/Latinx, Afro-Latino/a/x or any other Black or Latin or Indigenous ancestry
  Available medical records to confirm IBD diagnosis (Crohn's disease, Ulcerative colitis, IBD undetermined (IBD-U)) Any age
  arm group label: Controls
  description: Self-identify as:
  Black, African, African American, Afro-Caribbean, Afro-Latino/a/x, or Hispanic/Latinx, Afro-Latino/a/x or any other Black or Latin or Indigenous ancestry No personal history of IBD, no family history of IBD, no history of unexplained chronic diarrhea/blood in stool/anemia/abdominal pain/weight loss Any age
  intervention type: Genetic
  intervention name: Blood or saliva sample collection
  description: Blood or saliva sample & clinical data collection
  arm group label: Controls
  arm group label: IBD Subjects
  Participation involves:
  
        One-time blood (preferred) or saliva sample Collection of clinical data
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mark Silverberg, MD PhD
  role: Principal Investigator
  affiliation: Sinai Health System
  last name: Joanne Stempak, MSc
  phone: 4165864800
  phone ext: 8399
  email: joanne.stempak@sinaihealth.ca
  last name: Jenny Lee, MKin
  phone: 416-586-4800
  phone ext: 2318
  email: jenny.lee2@sinaihealth.ca
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: Mount Sinai Hospital, Canada
  investigator full name: Mark Silverberg
  investigator title: Dr.
  mesh term: Crohn Disease
  mesh term: Intestinal Diseases
  mesh term: Inflammatory Bowel Diseases
  sharing ipd: Undecided