<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/NCT03260842</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-19286</org_study_id>
    <secondary_id>U01CA210020</secondary_id>
    <nct_id>NCT03260842</nct_id>
  </id_info>
  <brief_title>Bio-Repository of High Risk Cohorts for the Early Detection of Pancreas Cancer</brief_title>
  <official_title>Bio-Repository of High Risk Cohorts for the Early Detection of Pancreas Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford 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>
      Bio-repository to collect bio-specimens from patients with 1) pancreatic cysts and 2)&#xD;
      patients at high risk, defined by family history and/or genetic mutations, for pancreatic&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Observational study to collect bio-specimens from 2 separate patient cohorts identified to be&#xD;
      at high risk for subsequent development of pancreas cancer.&#xD;
&#xD;
        1. Patients diagnosed with a pancreatic cyst undergoing either endoscopic ultrasound or&#xD;
           surgery. Bio-specimens collected include pancreatic cyst fluid and blood. These will be&#xD;
           collected using a standard operating protocol within the NIH Pancreatic Cancer Detection&#xD;
           Consortium.&#xD;
&#xD;
        2. Patients defined as a high risk individual for pancreas cancer by family history and/or&#xD;
           known genetic mutations. Bio-specimens collected include blood. This will be collected&#xD;
           using a standard operating protocol within the NIH Pancreatic Cancer Detection&#xD;
           Consortium.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">April 30, 2030</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2028</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>Pancreas Cancer</measure>
    <time_frame>5-10 years</time_frame>
    <description>Development of Pancreas Cancer</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Pancreatic Cyst</condition>
  <condition>Pancreas Disease</condition>
  <arm_group>
    <arm_group_label>Pancreatic Cysts</arm_group_label>
    <description>Patients with pancreatic cyst undergoing endoscopic ultrasound and/or surgery who will have bio-specimens collected</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Risk Individuals</arm_group_label>
    <description>Patients with established family history and/or genetic mutations for Pancreas cancer who will have bio-specimens collected</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Bio-Specimen Collection</intervention_name>
    <description>Collection of bio-specimens and observation over time.</description>
    <arm_group_label>High Risk Individuals</arm_group_label>
    <arm_group_label>Pancreatic Cysts</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood and Pancreatic Cyst Fluid&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients at high risk for developing pancreas cancer defined by the presence of a&#xD;
        pancreatic cyst and/or family history or genetic mutation for pancreas cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Older than 18 with pancreas cyst&#xD;
&#xD;
          -  Older than 18 at high risk for Pancreas cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide consent&#xD;
&#xD;
          -  Not willing to provide bio-specimens&#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>Walter Park, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Walter Park, MD</last_name>
    <phone>650-723-4102</phone>
    <email>wgpark@stanford.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sharon Pneh</last_name>
    <phone>650-724-1336</phone>
    <email>spneh@stanford.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94035</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Walter Park, MD</last_name>
      <email>wgpark@stanford.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>April 13, 2023</last_update_submitted>
  <last_update_submitted_qc>April 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Walter G. Park, M.D., M.S.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>early detection</keyword>
  <keyword>biomarkers</keyword>
  <keyword>pancreas cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Pancreatic Cyst</mesh_term>
    <mesh_term>Pancreatic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>De-identified clinical and demographic variables may be shared and linked to bio-specimens.</ipd_description>
  </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/NCT03260842
org study id: IRB-19286
secondary id: U01CA210020
nct id: NCT03260842
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Bio-repository to collect bio-specimens from patients with 1) pancreatic cysts and 2)
      patients at high risk, defined by family history and/or genetic mutations, for pancreatic
      cancer.
Observational study to collect bio-specimens from 2 separate patient cohorts identified to be
      at high risk for subsequent development of pancreas cancer.

        1. Patients diagnosed with a pancreatic cyst undergoing either endoscopic ultrasound or
           surgery. Bio-specimens collected include pancreatic cyst fluid and blood. These will be
           collected using a standard operating protocol within the NIH Pancreatic Cancer Detection
           Consortium.

        2. Patients defined as a high risk individual for pancreas cancer by family history and/or
           known genetic mutations. Bio-specimens collected include blood. This will be collected
           using a standard operating protocol within the NIH Pancreatic Cancer Detection
           Consortium.
observational model: Cohort
time perspective: Prospective
measure: Pancreas Cancer
time frame: 5-10 years
description: Development of Pancreas Cancer
arm group label: Pancreatic Cysts
description: Patients with pancreatic cyst undergoing endoscopic ultrasound and/or surgery who will have bio-specimens collected
arm group label: High Risk Individuals
description: Patients with established family history and/or genetic mutations for Pancreas cancer who will have bio-specimens collected
intervention type: Diagnostic Test
intervention name: Bio-Specimen Collection
description: Collection of bio-specimens and observation over time.
arm group label: High Risk Individuals
arm group label: Pancreatic Cysts
Blood and Pancreatic Cyst Fluid
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Walter Park, MD
role: Principal Investigator
affiliation: Faculty
last name: Walter Park, MD
phone: 650-723-4102
email: wgpark@stanford.edu
last name: Sharon Pneh
phone: 650-724-1336
email: spneh@stanford.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Walter G. Park, M.D., M.S.
investigator title: Principal Investigator
mesh term: Pancreatic Neoplasms
mesh term: Pancreatic Cyst
mesh term: Pancreatic Diseases
sharing ipd: Undecided
ipd description: De-identified clinical and demographic variables may be shared and linked to bio-specimens.