<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/NCT01662609</url>
  </required_header>
  <id_info>
    <org_study_id>MCC-14882</org_study_id>
    <nct_id>NCT01662609</nct_id>
  </id_info>
  <brief_title>Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer</brief_title>
  <official_title>Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer at Moffitt Cancer Center and Lehigh Valley Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>H. Lee Moffitt Cancer Center and Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>H. Lee Moffitt Cancer Center and Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find out whether Endoscopic Ultrasound (EUS) can detect early&#xD;
      stage pre-cancerous or cancerous changes in the pancreas in patients at high-risk for the&#xD;
      development of pancreatic cancer. Endoscopic refers to the use of an instrument called an&#xD;
      endoscope - a thin, flexible tube with a tiny video camera and light on the end. Ultrasound&#xD;
      refers to an imaging technique that uses sound waves to produce pictures. EUS in this&#xD;
      research study is a method of combining endoscopy and ultrasound imaging to obtain high&#xD;
      quality images of the pancreas.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 23, 2007</start_date>
  <completion_date type="Actual">August 16, 2022</completion_date>
  <primary_completion_date type="Actual">August 16, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Abnormalities Detected by EUS</measure>
    <time_frame>Average of 5 years</time_frame>
    <description>To determine whether targeted screening of these high-risk individuals using Endoscopic Ultrasound (EUS) at regular intervals can detect precancerous pancreas changes or early stage asymptomatic pancreatic cancer.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>Endoscopic Ultrasound (EUS) Participants</arm_group_label>
    <description>High-risk for Pancreatic Cancer: Patients with 2 or more relatives with pancreatic cancer and a first degree relationship with at least one of the relatives with pancreatic cancer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic Ultrasound (EUS)</intervention_name>
    <description>Ultrasound scope will be passed through the participant's mouth into their stomach and their pancreas will be evaluated completely by the ultrasound scope. If an abnormality is found in their pancreas, a biopsy may be performed to obtain a diagnosis.</description>
    <arm_group_label>Endoscopic Ultrasound (EUS) Participants</arm_group_label>
    <other_name>ultrasound scope</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals potentially at high-risk for developing pancreatic cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients will be eligible if they have 2 or more relatives with pancreatic cancer and&#xD;
             have a first degree relationship with at least one of the relatives with pancreatic&#xD;
             cancer&#xD;
&#xD;
               -  If only 2 family members are affected then both must have had pancreatic cancer&#xD;
                  and a first-degree relationship with individual screened&#xD;
&#xD;
               -  If there are more than 2 affected individuals on the same side of the family at&#xD;
                  least one of the individuals must have a first-degree relationship with the&#xD;
                  member being screened&#xD;
&#xD;
               -  Patients at least 40 years old or 10 years younger than the youngest affected&#xD;
                  individual&#xD;
&#xD;
          -  Peutz-Jeghers Syndrome (PJS) patients age&gt;30&#xD;
&#xD;
          -  Hereditary pancreatitis patients&#xD;
&#xD;
          -  Patients with Familial Atypical Multiple Mole Melanoma Syndrome (FAMMM)&#xD;
&#xD;
          -  Patients with BRCA2 mutation and at least one first or second degree relative with&#xD;
             documented pancreatic cancer&#xD;
&#xD;
          -  Willingness to undergo (EUS) with possible Fine Needle Aspiration (FNA)&#xD;
&#xD;
          -  Willingness to undergo surgical evaluation for abnormal EUS/FNA finding&#xD;
&#xD;
          -  Willingness to undergo radiographic evaluation if screening findings are abnormal&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical contraindications to undergoing endoscopy or obstruction of the GI tract that&#xD;
             precludes passage of the endoscope&#xD;
&#xD;
          -  Personal history of pancreatic adenocarcinoma&#xD;
&#xD;
          -  Previous partial or complete resection of the pancreas for adenocarcinoma&#xD;
&#xD;
          -  Prior partial or total gastrectomy with Billroth II or Roux-en-Y anastamosis&#xD;
&#xD;
          -  Previous computed tomography (CT) scan, magnetic resonance imaging/magnetic resonance&#xD;
             cholangiopancreatography (MRI/MRCP) or EUS of the abdomen in the past 3 years&#xD;
&#xD;
          -  Coexisting cancer in other organs or acquired immunodeficiency syndrome/human&#xD;
             immunodeficiency virus (AIDS/HIV)&#xD;
&#xD;
          -  Life expectancy less than 5 years&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aamir Dam, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>H. Lee Moffitt Cancer Center and Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>H. Lee Moffitt Cancer Center and Research Institute</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Health Network</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.moffitt.org/clinical-trials-research/</url>
    <description>Moffitt Cancer Center Clinical Trials website</description>
  </link>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>October 6, 2022</last_update_submitted>
  <last_update_submitted_qc>October 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pancreas</keyword>
  <keyword>high-risk</keyword>
  <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/NCT01662609
org study id: MCC-14882
nct id: NCT01662609
lead sponsor: 
has dmc: No
The purpose of this study is to find out whether Endoscopic Ultrasound (EUS) can detect early
      stage pre-cancerous or cancerous changes in the pancreas in patients at high-risk for the
      development of pancreatic cancer. Endoscopic refers to the use of an instrument called an
      endoscope - a thin, flexible tube with a tiny video camera and light on the end. Ultrasound
      refers to an imaging technique that uses sound waves to produce pictures. EUS in this
      research study is a method of combining endoscopy and ultrasound imaging to obtain high
      quality images of the pancreas.
observational model: Case-Only
time perspective: Prospective
measure: Number of Abnormalities Detected by EUS
time frame: Average of 5 years
description: To determine whether targeted screening of these high-risk individuals using Endoscopic Ultrasound (EUS) at regular intervals can detect precancerous pancreas changes or early stage asymptomatic pancreatic cancer.
arm group label: Endoscopic Ultrasound (EUS) Participants
description: High-risk for Pancreatic Cancer: Patients with 2 or more relatives with pancreatic cancer and a first degree relationship with at least one of the relatives with pancreatic cancer.
intervention type: Procedure
intervention name: Endoscopic Ultrasound (EUS)
description: Ultrasound scope will be passed through the participant's mouth into their stomach and their pancreas will be evaluated completely by the ultrasound scope. If an abnormality is found in their pancreas, a biopsy may be performed to obtain a diagnosis.
arm group label: Endoscopic Ultrasound (EUS) Participants
other name: ultrasound scope
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Aamir Dam, M.D.
role: Principal Investigator
affiliation: H. Lee Moffitt Cancer Center and Research Institute
facility: 
facility: 
country: United States
url: https://www.moffitt.org/clinical-trials-research/
description: Moffitt Cancer Center Clinical Trials website
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms