<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/NCT02247934</url>
  </required_header>
  <id_info>
    <org_study_id>A-13601-000</org_study_id>
    <nct_id>NCT02247934</nct_id>
  </id_info>
  <brief_title>Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)</brief_title>
  <official_title>Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gilead Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this qualitative study are to elicit concepts about symptoms that are&#xD;
      important to patients with primary sclerosing cholangitis (PSC), as well as the key impacts&#xD;
      of symptoms on patients' day-to-day functioning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Step I, concept elicitation one-on-one interviews (via telephone or in person) will be&#xD;
      conducted. The aims of the concept elicitation interviews are to:&#xD;
&#xD;
        1. Identify the most common symptoms, as well as the most important symptoms, for patients&#xD;
           with PSC, and&#xD;
&#xD;
        2. Assess whether these symptoms impact day-to-day functioning&#xD;
&#xD;
      An instrument will be developed based on the symptoms reported and in Step II of the study,&#xD;
      the performance of the instrument will be assessed with further interviews.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>List Primary Sclerosing Cholangitis (PSC) Symptoms for inclusion in patient questionnaire</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Interview participants to generate a list of the most common symptoms, as well as the most important symptoms, experienced by patients with PSC, and whether each symptom impacts day-to-day functioning.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">26</enrollment>
  <condition>Primary Sclerosing Cholangitis</condition>
  <arm_group>
    <arm_group_label>Concept elicitation interviews (Step I)</arm_group_label>
    <description>Approximately 20 participants will be included.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cognitive interviews (Step II)</arm_group_label>
    <description>Approximately 30 participants will be included.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be recruited from approximately 5 clinical sites based in the United&#xD;
        States.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed diagnosis of PSC based on liver biopsy or diagnostic imaging, with diagnosis&#xD;
             made at least three months prior to screening&#xD;
&#xD;
          -  Patient report of PSC symptoms associated with PSC diagnosis&#xD;
&#xD;
          -  Able to speak, read, and understand English&#xD;
&#xD;
          -  Willing and able to provide written informed consent to participate in the research&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with other causes of liver or biliary disease, including viral hepatitis,&#xD;
             alcoholic liver disease, primary biliary cirrhosis, and secondary sclerosing&#xD;
             cholangitis&#xD;
&#xD;
          -  Patient with history of liver cirrhosis&#xD;
&#xD;
          -  Patients with history of cholangiocarcinoma&#xD;
&#xD;
          -  Patients who have received a liver transplant&#xD;
&#xD;
          -  Patients currently enrolled in PSC clinical trials; and&#xD;
&#xD;
          -  STEP II ONLY: Enrolled in or participated in Step I of this study (concept&#xD;
             elicitation)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rob Myers, MD</last_name>
    <role>Study Director</role>
    <affiliation>Gilead Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Hospital, Denver Health Medical Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami Miller School of Medicine - Schiff Center for Liver Diseases</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Evidera</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Organ Care Research Swedish Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>February 8, 2016</last_update_submitted>
  <last_update_submitted_qc>February 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Primary sclerosing cholangitis</keyword>
  <keyword>PSC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangitis</mesh_term>
    <mesh_term>Cholangitis, Sclerosing</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/NCT02247934
org study id: A-13601-000
nct id: NCT02247934
lead sponsor: 
has dmc: No
The objectives of this qualitative study are to elicit concepts about symptoms that are
      important to patients with primary sclerosing cholangitis (PSC), as well as the key impacts
      of symptoms on patients' day-to-day functioning.
In Step I, concept elicitation one-on-one interviews (via telephone or in person) will be
      conducted. The aims of the concept elicitation interviews are to:

        1. Identify the most common symptoms, as well as the most important symptoms, for patients
           with PSC, and

        2. Assess whether these symptoms impact day-to-day functioning

      An instrument will be developed based on the symptoms reported and in Step II of the study,
      the performance of the instrument will be assessed with further interviews.
time perspective: Cross-Sectional
measure: List Primary Sclerosing Cholangitis (PSC) Symptoms for inclusion in patient questionnaire
time frame: Up to 12 months
description: Interview participants to generate a list of the most common symptoms, as well as the most important symptoms, experienced by patients with PSC, and whether each symptom impacts day-to-day functioning.
arm group label: Concept elicitation interviews (Step I)
description: Approximately 20 participants will be included.
arm group label: Cognitive interviews (Step II)
description: Approximately 30 participants will be included.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Rob Myers, MD
role: Study Director
affiliation: Gilead Sciences
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cholangitis
mesh term: Cholangitis, Sclerosing