<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/NCT01676324</url>
  </required_header>
  <id_info>
    <org_study_id>H12-01499</org_study_id>
    <nct_id>NCT01676324</nct_id>
  </id_info>
  <brief_title>FOCUS: The Future of Fecal Calprotectin Utility Study for the Diagnosis and Management of Inflammatory Bowel Disease (IBD)</brief_title>
  <acronym>FOCUS</acronym>
  <official_title>FOCUS: The Future of Fecal Calprotectin Utility Study for the Diagnosis and Management of IBD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypothesis:&#xD;
&#xD;
      Fecal Calprotectin will be useful in guiding the diagnosis and management of patients with&#xD;
      Inflammatory Bowel Disease. Fecal Calprotectin can be utilized as an alternative to&#xD;
      colonoscopy in the management of patients with Inflammatory Bowel Disease.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      By means of a survey from the ordering physician we would assess:&#xD;
&#xD;
      Primary Endpoint&#xD;
&#xD;
      1. The Percentage of time that the Fecal Calprotectin result caused the physician to change&#xD;
      the management of a patient.&#xD;
&#xD;
      Secondary Endpoints&#xD;
&#xD;
        1. To determine if the Fecal Calprotectin result influenced the number of endoscopies&#xD;
           performed&#xD;
&#xD;
        2. To correlate how well the Fecal Calprotectin correlates with Endoscopic findings when&#xD;
           endoscopy was performed.&#xD;
&#xD;
        3. To assess the correlation between the Fecal Calprotectin level and symptoms as measured&#xD;
           by the Harvey Bradshaw index or the partial Mayo Score (or full Mayo Score depending if&#xD;
           endoscopy was performed).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be identified as eligible by the attending Gastroenterologist during the course&#xD;
      of a usual consultation. Patients will be referred to the research nurse in the doctor's&#xD;
      office for further information regarding the study and informed consent will be obtained by&#xD;
      the research nurse.&#xD;
&#xD;
      Upon enrollment, the physician or the research nurse will complete an online requisition form&#xD;
      with a unique code which will provide the baseline data. The patient will be provided with&#xD;
      the Easy Sampler™ collection kit and instructions on the use of this kit and location on&#xD;
      where to send the specimen.&#xD;
&#xD;
      The nurse will then send an email to the research nurse in the originating physician's office&#xD;
      with the result of the calprotectin assay. The research nurse will review the result with the&#xD;
      physician. After physician review, either the physician or the research nurse will then&#xD;
      complete a follow up survey online.&#xD;
&#xD;
      After completion of the assays and surveys, the data will be tabulated electronically from&#xD;
      the online website and analyzed by the PI and/or co-investigators.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Percentage of time that Fecal Calprotectin result caused the physician to change the management of a patient.</measure>
    <time_frame>one year</time_frame>
    <description>The utility of the test will be assessed by comparing the proportion of time the test altered management for each of the two groups (IBD present vs. IBD absent). The groups will be compared using paired t-tests and McNemar's test as appropriate. Multivariate analysis will be used to assess the impact of the baseline variables on the test utility.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">289</enrollment>
  <condition>Inflammatory Bowel Disease</condition>
  <condition>Crohn's Disease</condition>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>Inflammatory Bowel Disease</arm_group_label>
    <description>Those with Inflammatory Bowel Disease (known) and those with no Inflammatory Bowel Disease (not previously diagnosed)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be those age 19 or older seen by community and academic gastroenterologists&#xD;
        and may be referred for Fecal Calprotectin testing at the discretion of the&#xD;
        Gastroenterologist.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must be at least 19 years of age or older, they must be able to read and&#xD;
             provide written consent in English.&#xD;
&#xD;
        Subjects will have gastrointestinal symptoms or be known to have Inflammatory Bowel Disease&#xD;
        whereby the clinician feels that obtaining Fecal Calprotectin may be useful in the care of&#xD;
        the patient. Patients must be able to collect a feces sample and return it for analysis&#xD;
        within 3 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known Ischemic colitis, infectious enteritis or colitis, known colorectal cancer,&#xD;
             history of extensive bowel resection, ostomy, current daily use of NSAIDs (aspirin,&#xD;
             ibuprofen, naproxen, etc) or the inability to collect sample and return it within 3&#xD;
             days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian Bressler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Medicine, Division of Gastroenterology, UBC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GI Research Institute (GIRI)</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z 2K5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Sutherland AD, Gearry RB, Frizelle FA. Review of fecal biomarkers in inflammatory bowel disease. Dis Colon Rectum. 2008 Aug;51(8):1283-91. doi: 10.1007/s10350-008-9310-8. Epub 2008 Jun 10.</citation>
    <PMID>18543035</PMID>
  </reference>
  <reference>
    <citation>Gisbert JP, Bermejo F, Perez-Calle JL, Taxonera C, Vera I, McNicholl AG, Algaba A, Lopez P, Lopez-Palacios N, Calvo M, Gonzalez-Lama Y, Carneros JA, Velasco M, Mate J. Fecal calprotectin and lactoferrin for the prediction of inflammatory bowel disease relapse. Inflamm Bowel Dis. 2009 Aug;15(8):1190-8. doi: 10.1002/ibd.20933.</citation>
    <PMID>19291780</PMID>
  </reference>
  <reference>
    <citation>Schoepfer AM, Beglinger C, Straumann A, Trummler M, Vavricka SR, Bruegger LE, Seibold F. Fecal calprotectin correlates more closely with the Simple Endoscopic Score for Crohn's disease (SES-CD) than CRP, blood leukocytes, and the CDAI. Am J Gastroenterol. 2010 Jan;105(1):162-9. doi: 10.1038/ajg.2009.545. Epub 2009 Sep 15.</citation>
    <PMID>19755969</PMID>
  </reference>
  <results_reference>
    <citation>Keohane J, O'Mahony C, O'Mahony L, O'Mahony S, Quigley EM, Shanahan F. Irritable bowel syndrome-type symptoms in patients with inflammatory bowel disease: a real association or reflection of occult inflammation? Am J Gastroenterol. 2010 Aug;105(8):1788, 1789-94; quiz 1795. doi: 10.1038/ajg.2010.156. Epub 2010 Apr 13.</citation>
    <PMID>20389294</PMID>
  </results_reference>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>June 5, 2014</last_update_submitted>
  <last_update_submitted_qc>June 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fecal Calprotectin</keyword>
  <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>
  <!-- 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/NCT01676324
org study id: H12-01499
nct id: NCT01676324
lead sponsor: 
has dmc: Yes
Hypothesis:

      Fecal Calprotectin will be useful in guiding the diagnosis and management of patients with
      Inflammatory Bowel Disease. Fecal Calprotectin can be utilized as an alternative to
      colonoscopy in the management of patients with Inflammatory Bowel Disease.

      Objectives:

      By means of a survey from the ordering physician we would assess:

      Primary Endpoint

      1. The Percentage of time that the Fecal Calprotectin result caused the physician to change
      the management of a patient.

      Secondary Endpoints

        1. To determine if the Fecal Calprotectin result influenced the number of endoscopies
           performed

        2. To correlate how well the Fecal Calprotectin correlates with Endoscopic findings when
           endoscopy was performed.

        3. To assess the correlation between the Fecal Calprotectin level and symptoms as measured
           by the Harvey Bradshaw index or the partial Mayo Score (or full Mayo Score depending if
           endoscopy was performed).
Patients will be identified as eligible by the attending Gastroenterologist during the course
      of a usual consultation. Patients will be referred to the research nurse in the doctor's
      office for further information regarding the study and informed consent will be obtained by
      the research nurse.

      Upon enrollment, the physician or the research nurse will complete an online requisition form
      with a unique code which will provide the baseline data. The patient will be provided with
      the Easy Sampler™ collection kit and instructions on the use of this kit and location on
      where to send the specimen.

      The nurse will then send an email to the research nurse in the originating physician's office
      with the result of the calprotectin assay. The research nurse will review the result with the
      physician. After physician review, either the physician or the research nurse will then
      complete a follow up survey online.

      After completion of the assays and surveys, the data will be tabulated electronically from
      the online website and analyzed by the PI and/or co-investigators.
observational model: Cohort
time perspective: Prospective
measure: Percentage of time that Fecal Calprotectin result caused the physician to change the management of a patient.
time frame: one year
description: The utility of the test will be assessed by comparing the proportion of time the test altered management for each of the two groups (IBD present vs. IBD absent). The groups will be compared using paired t-tests and McNemar's test as appropriate. Multivariate analysis will be used to assess the impact of the baseline variables on the test utility.
arm group label: Inflammatory Bowel Disease
description: Those with Inflammatory Bowel Disease (known) and those with no Inflammatory Bowel Disease (not previously diagnosed)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Brian Bressler, MD
role: Principal Investigator
affiliation: Department of Medicine, Division of Gastroenterology, UBC
facility: 
country: Canada
citation: Sutherland AD, Gearry RB, Frizelle FA. Review of fecal biomarkers in inflammatory bowel disease. Dis Colon Rectum. 2008 Aug;51(8):1283-91. doi: 10.1007/s10350-008-9310-8. Epub 2008 Jun 10.
PMID: 18543035
citation: Gisbert JP, Bermejo F, Perez-Calle JL, Taxonera C, Vera I, McNicholl AG, Algaba A, Lopez P, Lopez-Palacios N, Calvo M, Gonzalez-Lama Y, Carneros JA, Velasco M, Mate J. Fecal calprotectin and lactoferrin for the prediction of inflammatory bowel disease relapse. Inflamm Bowel Dis. 2009 Aug;15(8):1190-8. doi: 10.1002/ibd.20933.
PMID: 19291780
citation: Schoepfer AM, Beglinger C, Straumann A, Trummler M, Vavricka SR, Bruegger LE, Seibold F. Fecal calprotectin correlates more closely with the Simple Endoscopic Score for Crohn's disease (SES-CD) than CRP, blood leukocytes, and the CDAI. Am J Gastroenterol. 2010 Jan;105(1):162-9. doi: 10.1038/ajg.2009.545. Epub 2009 Sep 15.
PMID: 19755969
citation: Keohane J, O'Mahony C, O'Mahony L, O'Mahony S, Quigley EM, Shanahan F. Irritable bowel syndrome-type symptoms in patients with inflammatory bowel disease: a real association or reflection of occult inflammation? Am J Gastroenterol. 2010 Aug;105(8):1788, 1789-94; quiz 1795. doi: 10.1038/ajg.2010.156. Epub 2010 Apr 13.
PMID: 20389294
responsible party type: Sponsor
mesh term: Crohn Disease
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases