<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/NCT02250638</url>
  </required_header>
  <id_info>
    <org_study_id>FDI-68</org_study_id>
    <nct_id>NCT02250638</nct_id>
  </id_info>
  <brief_title>Longitudinal Pancreatic Cancer Study</brief_title>
  <official_title>A Prospective Longitudinal Study of CA 19-9 as an Aid in Monitoring Disease in Patients With Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fujirebio Diagnostics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fujirebio Diagnostics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To obtain sufficient specimens and correlating clinical data from a well-controlled&#xD;
      prospective clinical trial collecting longitudinal specimens from subjects diagnosed with any&#xD;
      stage of pancreatic cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study objectives are described below:&#xD;
&#xD;
        1. Obtain serum and plasma specimens longitudinally collected from approximately 140&#xD;
           subjects diagnosed with pancreatic cancer and are about to or are currently undergoing&#xD;
           treatment and follow-up. Specimens will be used to evaluate CA 19-9 assays, currently&#xD;
           under development, as an aid for monitoring recurrence or progressive disease.&#xD;
&#xD;
        2. To store any remaining specimens for use in future cancer research and to evaluate as&#xD;
           yet undetermined biomarkers for the development of IVDs, including additional CA 19-9&#xD;
           assays, for monitoring the course of disease and therapy in subjects diagnosed with&#xD;
           pancreatic cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</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>A Prospective Longitudinal Study of CA 19-9 as an Aid in Monitoring Disease in Patients with Pancreatic Cancer</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Pancreatic Cancer</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CA 19-9 Assay</intervention_name>
    <description>Physicians use the CA 19-9 test results to manage their patients</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum and Plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Approximately 140 subjects will be enrolled in this study. Women and men greater than or&#xD;
        equal to 18 years of age with a histologically/pathologically confirmed diagnosis of&#xD;
        pancreatic cancer and a minimum of three serial blood draws collected at disease evaluation&#xD;
        time points, as determined by the treating physician's standard of care, will be eligible.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females, age≥ 18 years&#xD;
&#xD;
          -  Histologic/pathologic confirmation of exocrine pancreatic cancer&#xD;
&#xD;
          -  Any stage of disease: Newly diagnosed, stable, disease progression&#xD;
&#xD;
          -  Any treatment time point: Treatment naïve, currently receiving or completed therapy&#xD;
             for pancreatic cancer including active monitoring.&#xD;
&#xD;
          -  Individuals with a history of malignant disease other than pancreatic cancer that was&#xD;
             resected greater than 5 years ago and are currently in remission are eligible.&#xD;
&#xD;
          -  Life expectancy greater than 6 months&#xD;
&#xD;
          -  Able to understand and willing to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Males and females, age &lt;18 years&#xD;
&#xD;
          -  No histologic/pathologic confirmation of exocrine pancreatic cancer&#xD;
&#xD;
          -  Life expectancy less than 6 months&#xD;
&#xD;
          -  Any concurrent malignancy other than basal or squamous cell skin cancers or in-situ&#xD;
             cervical cancer.&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Diana Dickson</last_name>
    <role>Study Director</role>
    <affiliation>Fujirebio Diagnostics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boca Raton Regional Hospital</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Broward Health Medical Center</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harry &amp; Jeanette Weinberg Cancer Institute</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas City VA Center</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Hanover Regional Medical Center</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GI Research Institute</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z2K5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>August 16, 2021</last_update_submitted>
  <last_update_submitted_qc>August 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</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/NCT02250638
org study id: FDI-68
nct id: NCT02250638
lead sponsor: 
has dmc: No
To obtain sufficient specimens and correlating clinical data from a well-controlled
      prospective clinical trial collecting longitudinal specimens from subjects diagnosed with any
      stage of pancreatic cancer.
The study objectives are described below:

        1. Obtain serum and plasma specimens longitudinally collected from approximately 140
           subjects diagnosed with pancreatic cancer and are about to or are currently undergoing
           treatment and follow-up. Specimens will be used to evaluate CA 19-9 assays, currently
           under development, as an aid for monitoring recurrence or progressive disease.

        2. To store any remaining specimens for use in future cancer research and to evaluate as
           yet undetermined biomarkers for the development of IVDs, including additional CA 19-9
           assays, for monitoring the course of disease and therapy in subjects diagnosed with
           pancreatic cancer.
observational model: Cohort
time perspective: Prospective
measure: A Prospective Longitudinal Study of CA 19-9 as an Aid in Monitoring Disease in Patients with Pancreatic Cancer
time frame: 3 years
intervention type: Other
intervention name: CA 19-9 Assay
description: Physicians use the CA 19-9 test results to manage their patients
Serum and Plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Diana Dickson
role: Study Director
affiliation: Fujirebio Diagnostics, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms