<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/NCT03756649</url>
  </required_header>
  <id_info>
    <org_study_id>18-007941</org_study_id>
    <nct_id>NCT03756649</nct_id>
  </id_info>
  <brief_title>Mayo Clinic IBD Biobank</brief_title>
  <official_title>Mayo Clinic IBD Biobank</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      Researchers are collecting and storing blood, stool, and urine samples and medical&#xD;
      information to better understand Inflammatory Bowel Disease (IBD) to improve disease outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be sent a letter detailing the proposed biobank and soliciting enrollment.&#xD;
      Following the informed consent process, subjects will provide a blood sample (50 ml), urine&#xD;
      sample (50 ml), and stool. The blood and urine samples will either be collected at the one of&#xD;
      the Mayo Clinic outpatient laboratories or by a mail-out kit. Subjects will be asked to&#xD;
      complete a questionnaire and 24-hour food recall questionnaire (completed online).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Anticipated">December 2065</completion_date>
  <primary_completion_date type="Anticipated">December 2065</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Study Participants</measure>
    <time_frame>50 years</time_frame>
    <description>Total number of participants in the study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urine Collection</measure>
    <time_frame>50 years</time_frame>
    <description>Total number of urine samples collected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Collection</measure>
    <time_frame>50 years</time_frame>
    <description>Total number of blood samples collected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool Collection</measure>
    <time_frame>50 years</time_frame>
    <description>Total number of stool samples collected</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>Subjects without inflammatory bowel disease (IBD) will have samples collected of blood, urine and stool</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inflammatory bowel disease (IBD)</arm_group_label>
    <description>Subjects with known inflammatory bowel disease will have samples collected of blood, urine and stool</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood Draw</intervention_name>
    <description>50 ml will be collected</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Inflammatory bowel disease (IBD)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Urine Collection</intervention_name>
    <description>50 ml will be collected</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Inflammatory bowel disease (IBD)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Stool Collection</intervention_name>
    <description>Three 25 ml tubes will be collected</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Inflammatory bowel disease (IBD)</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood work to be obtained from patient to be processed and stored until needed in the future&#xD;
      for potential research.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with inflammatory bowel disease (IBD) who are between the ages of 18 and&#xD;
        85 at time of study enrollment.&#xD;
&#xD;
          -  The diagnosis of IBD will be based on the standard IBD criteria including biochemical&#xD;
             and colonoscopy screening.&#xD;
&#xD;
          -  Women with inflammatory bowel disease of childbearing potential and pregnant women&#xD;
             will be offered enrollment because there is no risk to an unborn child in this&#xD;
             investigation.&#xD;
&#xD;
          -  Patients between the ages of 18 and 85 without history of IBD or colon cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with inflammatory bowel disease (IBD) who are between the ages of&#xD;
             18 and 85 at time of study enrollment.&#xD;
&#xD;
          -  The diagnosis of IBD will be based on the standard IBD criteria including biochemical&#xD;
             and colonoscopy screening.&#xD;
&#xD;
          -  Women with inflammatory bowel disease of childbearing potential and pregnant women&#xD;
             will be offered enrollment because there is no risk to an unborn child in this&#xD;
             investigation.&#xD;
&#xD;
          -  Patients between the ages of 18 and 85 without history of IBD or colon cancer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known liver disease.&#xD;
&#xD;
          -  Patients unable to provide informed consent.&#xD;
&#xD;
          -  Prisoners and institutionalized individuals.&#xD;
&#xD;
          -  Patients with a history of colorectal cancer.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Konstantinos N. Lazaridis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>January 9, 2023</last_update_submitted>
  <last_update_submitted_qc>January 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Konstantinos N. Lazaridis, M.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>IBD</keyword>
  <keyword>Ulcerative colitis</keyword>
  <keyword>Crohn's</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammatory Bowel Diseases</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/NCT03756649
org study id: 18-007941
nct id: NCT03756649
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Researchers are collecting and storing blood, stool, and urine samples and medical
      information to better understand Inflammatory Bowel Disease (IBD) to improve disease outcome.
Subjects will be sent a letter detailing the proposed biobank and soliciting enrollment.
      Following the informed consent process, subjects will provide a blood sample (50 ml), urine
      sample (50 ml), and stool. The blood and urine samples will either be collected at the one of
      the Mayo Clinic outpatient laboratories or by a mail-out kit. Subjects will be asked to
      complete a questionnaire and 24-hour food recall questionnaire (completed online).
observational model: Case-Only
time perspective: Prospective
measure: Study Participants
time frame: 50 years
description: Total number of participants in the study
measure: Urine Collection
time frame: 50 years
description: Total number of urine samples collected
measure: Blood Collection
time frame: 50 years
description: Total number of blood samples collected
measure: Stool Collection
time frame: 50 years
description: Total number of stool samples collected
arm group label: Control Group
description: Subjects without inflammatory bowel disease (IBD) will have samples collected of blood, urine and stool
arm group label: Inflammatory bowel disease (IBD)
description: Subjects with known inflammatory bowel disease will have samples collected of blood, urine and stool
intervention type: Procedure
intervention name: Blood Draw
description: 50 ml will be collected
arm group label: Control Group
arm group label: Inflammatory bowel disease (IBD)
intervention type: Procedure
intervention name: Urine Collection
description: 50 ml will be collected
arm group label: Control Group
arm group label: Inflammatory bowel disease (IBD)
intervention type: Procedure
intervention name: Stool Collection
description: Three 25 ml tubes will be collected
arm group label: Control Group
arm group label: Inflammatory bowel disease (IBD)
Blood work to be obtained from patient to be processed and stored until needed in the future
      for potential research.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Konstantinos N. Lazaridis, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Konstantinos N. Lazaridis, M.D.
investigator title: Principal Investigator
mesh term: Inflammatory Bowel Diseases