<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/NCT03001505</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00075769</org_study_id>
    <nct_id>NCT03001505</nct_id>
  </id_info>
  <brief_title>Registry for Pancreatic Cancer</brief_title>
  <official_title>Registry to Evaluate Multi-modality Therapies for Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</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>
      This is an observational, prospective and retrospective registry of patients with pancreatic&#xD;
      cancer treated in Duke University Health System, which will examine patient and treatment&#xD;
      effects on cancer outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study design changed to clinical database only with no research question to be studied.&#xD;
  </why_stopped>
  <start_date type="Actual">May 4, 2017</start_date>
  <completion_date type="Anticipated">April 2037</completion_date>
  <primary_completion_date type="Anticipated">April 2037</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>Other</time_perspective>
  </study_design_info>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>10 years</time_frame>
    <description>Survival from Diagnosis to time of death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>10 years</time_frame>
    <description>length of time with no evidence of disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metastasis</measure>
    <time_frame>10 years</time_frame>
    <description>Radiographic or surgical evidence of disease spread beyond the pancreas (or resection bed if post surgery).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local recurrence</measure>
    <time_frame>10 years</time_frame>
    <description>Radiographic evidence of disease recurrence in the resection bed, if post surgery.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>Patients with pancreatic cancer</arm_group_label>
    <description>Patients diagnosed with pancreatic cancer evaluated at this institution.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with pancreatic cancer who are treated at DUHS&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pancreatic cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 18 years of age&#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>Sabino Zani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>DUHS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Health System</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>December 4, 2017</last_update_submitted>
  <last_update_submitted_qc>December 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2017</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>
  <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/NCT03001505
org study id: Pro00075769
nct id: NCT03001505
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an observational, prospective and retrospective registry of patients with pancreatic
      cancer treated in Duke University Health System, which will examine patient and treatment
      effects on cancer outcomes.
observational model: Cohort
time perspective: Other
measure: Overall survival
time frame: 10 years
description: Survival from Diagnosis to time of death
measure: Disease-free survival
time frame: 10 years
description: length of time with no evidence of disease
measure: Metastasis
time frame: 10 years
description: Radiographic or surgical evidence of disease spread beyond the pancreas (or resection bed if post surgery).
measure: Local recurrence
time frame: 10 years
description: Radiographic evidence of disease recurrence in the resection bed, if post surgery.
arm group label: Patients with pancreatic cancer
description: Patients diagnosed with pancreatic cancer evaluated at this institution.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sabino Zani, MD
role: Principal Investigator
affiliation: DUHS
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
sharing ipd: No