<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/NCT03778918</url>
  </required_header>
  <id_info>
    <org_study_id>XC18TEDI0027</org_study_id>
    <nct_id>NCT03778918</nct_id>
  </id_info>
  <brief_title>The Comparison Between the Biomarkers in Inflammatory Bowel Disease Patients and General Control Group</brief_title>
  <official_title>The Comparison Between That Expression Pattern and Disease Activity of Variable Biomarkers in Inflammatory Bowel Disease Patients and General Control Group. Multicenter, Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bo-In Lee</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Incheon St.Mary's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St Vincent's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Daejeon St. Mary's hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul St. Mary's Hospital</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>
      The aims of this study is to investigate a blood-based biomarker that can replace endoscopy&#xD;
      in patients with inflammatory bowel disease. For this purpose, blood sample of patients wiht&#xD;
      inflammatory bowel disease (ulcerative colitis, Crohn 's disease) was collected at the same&#xD;
      time the endoscopy is performed, stored after centrifugation, and analyzed accordingly.&#xD;
      Selected biomarkers from the blood sample were investigated to compare those of patients with&#xD;
      inflammatory bowel disease and those of general controls. Males and females over the age of&#xD;
      19 participated in the study and are excluded if they have chronic kidney disease or blood&#xD;
      clotting disease. The outcome is a find of a blood-based biomarker that best reflects a&#xD;
      disease activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inflammatory bowel disease refers to chronic inflammation of the unknown origin that occurs&#xD;
      in the intestine. It usually refers to ulcerative colitis and Crohn's disease, which are&#xD;
      idiopathic inflammatory bowel diseases. While it had been known to be a common disease in the&#xD;
      western world, in recent decades the incidence of ulcerative colitis and Crohn's disease has&#xD;
      rapidly increased in Korea as well. Endoscopic examination is a gold standard in order to&#xD;
      determine the activity of inflammatory bowel disease, but it is hardly performed due to the&#xD;
      cost and time of a test. Therefore, it is necessary to find a blood-based biomarker that&#xD;
      replaces endoscopy. The objective of the study is to identify a new inflammatory marker that&#xD;
      replaces endoscopy by comparing blood samples of patients with inflammatory bowel disease&#xD;
      with those of general controls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2016</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>36 Months</target_duration>
  <primary_outcome>
    <measure>measurement of blood-based biomarkers to predict disease activity 1</measure>
    <time_frame>within 12 weeks of the blood sampling</time_frame>
    <description>REG3 alpha (ng/mL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>measurement of blood-based biomarkers to predict disease activity 2</measure>
    <time_frame>within 12 weeks of the blood sampling</time_frame>
    <description>hs-CRP (mg/dL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>measurement of blood-based biomarkers to predict disease activity 3</measure>
    <time_frame>within 12 weeks of the blood sampling</time_frame>
    <description>serum calprotectin (ng/mL)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Age (years)</measure>
    <time_frame>at the time of study enrolled</time_frame>
    <description>age at the time of study enrolled</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gender (M/F)</measure>
    <time_frame>at the time of study enrolled</time_frame>
    <description>male of female</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>disease duration (months)</measure>
    <time_frame>at the time of study enrolled</time_frame>
    <description>duration of disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>disease onset (years)</measure>
    <time_frame>at the time of study enrolled</time_frame>
    <description>age at which the disease begins</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <condition>Irritable Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>inflammatory bowel disease</arm_group_label>
    <description>inflammatory bowel disease such as Ulcerative colitis and Crohn's disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IBS or Normal Control</arm_group_label>
    <description>irritable bowel syndrome patients normal patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>inflammatory bowel disease</intervention_name>
    <description>blood based biomarkers in IBD such as REG3 alpha, serum calprotectin and hs-CRP</description>
    <arm_group_label>IBS or Normal Control</arm_group_label>
    <arm_group_label>inflammatory bowel disease</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>IBS or Normal Control</intervention_name>
    <description>blood based biomarker compared normal control with IBD</description>
    <arm_group_label>IBS or Normal Control</arm_group_label>
    <arm_group_label>inflammatory bowel disease</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, Biopsy tissue, Stool&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        inflammatory bowel disease (ulcerative colitis, Crohn's Dz.) irritable bowel syndrome&#xD;
        normal control&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  people who receive colonoscopy&#xD;
&#xD;
          -  people who sign the consent&#xD;
&#xD;
          -  having inflammatory bowel disease (ulcerative colitis, Crohn's Dz.) and irritable&#xD;
             bowel syndrome&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  those aged over 75 years&#xD;
&#xD;
          -  the disabled&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  chronic renal diseases (CLcr &lt;50ml/min)&#xD;
&#xD;
          -  blood coagulopathy (PT INR &gt; 1.5, aPTT &gt; 45 seconds, or platelet count &lt; 50,000/mm)&#xD;
&#xD;
          -  people who refuse to sign the consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bo-In Lee, MD. Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul St. Mary's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bo-In Lee, MD. Ph.D.</last_name>
    <phone>82-10-8367-1055</phone>
    <email>gidoc4u@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Seungjun Kim, MD.</last_name>
    <phone>82-10-8786-2799</phone>
    <email>gmt475@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Division of Gastroenterology; Seoul St. Mary's hospital</name>
      <address>
        <city>Seoul</city>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bo-In Lee, MD, PhD</last_name>
      <phone>82-10-8367-1055</phone>
      <email>gidoc4u@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Bo-In Lee, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Darnaud M, Dos Santos A, Gonzalez P, Augui S, Lacoste C, Desterke C, De Hertogh G, Valentino E, Braun E, Zheng J, Boisgard R, Neut C, Dubuquoy L, Chiappini F, Samuel D, Lepage P, Guerrieri F, Dore J, Brechot C, Moniaux N, Faivre J. Enteric Delivery of Regenerating Family Member 3 alpha Alters the Intestinal Microbiota and Controls Inflammation in Mice With Colitis. Gastroenterology. 2018 Mar;154(4):1009-1023.e14. doi: 10.1053/j.gastro.2017.11.003. Epub 2017 Nov 11.</citation>
    <PMID>29133078</PMID>
  </reference>
  <reference>
    <citation>Greuter T, Lang S, Holler E, Hawkey CJ, Rogler G, Biedermann L; ASTIC trial group. Serum REG3alpha and C-Reactive Protein Levels in Crohn's Disease Patients Undergoing Immunoablation and Autologous Hemopoetic Stem Cell Transplantation in the ASTIC Trial. Digestion. 2015;92(2):83-9. doi: 10.1159/000437300. Epub 2015 Aug 1.</citation>
    <PMID>26278889</PMID>
  </reference>
  <reference>
    <citation>Harris AC, Levine JE, Ferrara JL. Have we made progress in the treatment of GVHD? Best Pract Res Clin Haematol. 2012 Dec;25(4):473-8. doi: 10.1016/j.beha.2012.10.010. Epub 2012 Oct 25.</citation>
    <PMID>23200544</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 16, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>March 2, 2020</last_update_submitted>
  <last_update_submitted_qc>March 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Seoul St. Mary's Hospital</investigator_affiliation>
    <investigator_full_name>Bo-In Lee</investigator_full_name>
    <investigator_title>Professor, MD, PhD.</investigator_title>
  </responsible_party>
  <keyword>REG3 alpha</keyword>
  <keyword>IBD</keyword>
  <keyword>biomarker</keyword>
  <keyword>ulcerative colitis</keyword>
  <keyword>serum calprotectin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03778918
org study id: XC18TEDI0027
nct id: NCT03778918
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aims of this study is to investigate a blood-based biomarker that can replace endoscopy
      in patients with inflammatory bowel disease. For this purpose, blood sample of patients wiht
      inflammatory bowel disease (ulcerative colitis, Crohn 's disease) was collected at the same
      time the endoscopy is performed, stored after centrifugation, and analyzed accordingly.
      Selected biomarkers from the blood sample were investigated to compare those of patients with
      inflammatory bowel disease and those of general controls. Males and females over the age of
      19 participated in the study and are excluded if they have chronic kidney disease or blood
      clotting disease. The outcome is a find of a blood-based biomarker that best reflects a
      disease activity.
Inflammatory bowel disease refers to chronic inflammation of the unknown origin that occurs
      in the intestine. It usually refers to ulcerative colitis and Crohn's disease, which are
      idiopathic inflammatory bowel diseases. While it had been known to be a common disease in the
      western world, in recent decades the incidence of ulcerative colitis and Crohn's disease has
      rapidly increased in Korea as well. Endoscopic examination is a gold standard in order to
      determine the activity of inflammatory bowel disease, but it is hardly performed due to the
      cost and time of a test. Therefore, it is necessary to find a blood-based biomarker that
      replaces endoscopy. The objective of the study is to identify a new inflammatory marker that
      replaces endoscopy by comparing blood samples of patients with inflammatory bowel disease
      with those of general controls.
observational model: Cohort
time perspective: Prospective
measure: measurement of blood-based biomarkers to predict disease activity 1
time frame: within 12 weeks of the blood sampling
description: REG3 alpha (ng/mL)
measure: measurement of blood-based biomarkers to predict disease activity 2
time frame: within 12 weeks of the blood sampling
description: hs-CRP (mg/dL)
measure: measurement of blood-based biomarkers to predict disease activity 3
time frame: within 12 weeks of the blood sampling
description: serum calprotectin (ng/mL)
measure: Age (years)
time frame: at the time of study enrolled
description: age at the time of study enrolled
measure: Gender (M/F)
time frame: at the time of study enrolled
description: male of female
measure: disease duration (months)
time frame: at the time of study enrolled
description: duration of disease
measure: disease onset (years)
time frame: at the time of study enrolled
description: age at which the disease begins
arm group label: inflammatory bowel disease
description: inflammatory bowel disease such as Ulcerative colitis and Crohn's disease
arm group label: IBS or Normal Control
description: irritable bowel syndrome patients normal patients
intervention type: Other
intervention name: inflammatory bowel disease
description: blood based biomarkers in IBD such as REG3 alpha, serum calprotectin and hs-CRP
arm group label: IBS or Normal Control
arm group label: inflammatory bowel disease
intervention type: Other
intervention name: IBS or Normal Control
description: blood based biomarker compared normal control with IBD
arm group label: IBS or Normal Control
arm group label: inflammatory bowel disease
Blood, Biopsy tissue, Stool
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bo-In Lee, MD. Ph.D.
role: Principal Investigator
affiliation: Seoul St. Mary's Hospital
last name: Bo-In Lee, MD. Ph.D.
phone: 82-10-8367-1055
email: gidoc4u@gmail.com
last name: Seungjun Kim, MD.
phone: 82-10-8786-2799
email: gmt475@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
citation: Darnaud M, Dos Santos A, Gonzalez P, Augui S, Lacoste C, Desterke C, De Hertogh G, Valentino E, Braun E, Zheng J, Boisgard R, Neut C, Dubuquoy L, Chiappini F, Samuel D, Lepage P, Guerrieri F, Dore J, Brechot C, Moniaux N, Faivre J. Enteric Delivery of Regenerating Family Member 3 alpha Alters the Intestinal Microbiota and Controls Inflammation in Mice With Colitis. Gastroenterology. 2018 Mar;154(4):1009-1023.e14. doi: 10.1053/j.gastro.2017.11.003. Epub 2017 Nov 11.
PMID: 29133078
citation: Greuter T, Lang S, Holler E, Hawkey CJ, Rogler G, Biedermann L; ASTIC trial group. Serum REG3alpha and C-Reactive Protein Levels in Crohn's Disease Patients Undergoing Immunoablation and Autologous Hemopoetic Stem Cell Transplantation in the ASTIC Trial. Digestion. 2015;92(2):83-9. doi: 10.1159/000437300. Epub 2015 Aug 1.
PMID: 26278889
citation: Harris AC, Levine JE, Ferrara JL. Have we made progress in the treatment of GVHD? Best Pract Res Clin Haematol. 2012 Dec;25(4):473-8. doi: 10.1016/j.beha.2012.10.010. Epub 2012 Oct 25.
PMID: 23200544
responsible party type: Sponsor-Investigator
investigator affiliation: Seoul St. Mary's Hospital
investigator full name: Bo-In Lee
investigator title: Professor, MD, PhD.
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
mesh term: Irritable Bowel Syndrome
sharing ipd: No