<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/NCT03033927</url>
  </required_header>
  <id_info>
    <org_study_id>17-042</org_study_id>
    <nct_id>NCT03033927</nct_id>
  </id_info>
  <brief_title>Predicting Effective Therapy in Pancreatic Cancer</brief_title>
  <official_title>Circulating Tumor Cell and Tumor Tissue Models for Predicting Effective Pancreatic Cancer Response</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this phase II study is to develop a test to predict response of pancreatic&#xD;
      cancer to different chemotherapy regimens.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 24, 2017</start_date>
  <completion_date type="Anticipated">January 24, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 24, 2024</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>Progression Free Survival</measure>
    <time_frame>36 months</time_frame>
    <description>in patients receiving frontline therapy predicted to be effective versus ineffective based on CTC PGx analysis</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">74</enrollment>
  <condition>Pancreatic Cancer</condition>
  <condition>Pancreatic Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Participants with Stage IV Pancreatic Cancer</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>CTC isolocation and analysis</intervention_name>
    <description>Circulating tumorigenic cell (CTC) isolation and enrichment will be performed using a proprietary invasion assay.</description>
    <arm_group_label>Participants with Stage IV Pancreatic Cancer</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Sodium heparin tube collections will be performed at baseline, at each restaging CT scan and&#xD;
      at time of first disease progression. K3-EDTA tubes will be collected at baseline and at&#xD;
      disease progression.&#xD;
&#xD;
      In patients who are planning an EGD for the purpose of obtaining a tumor biopsy, portal vein&#xD;
      sampling will be offered. Under EUS guidance, a 19-gauge EUS fine needle will be advanced&#xD;
      transhepatically into the portal vein and as many as four 7.5 mL K3-EDTA samples of blood&#xD;
      will be aspirated, as previously described. Research biopsy will be performed at baseline&#xD;
      and, if feasible, at disease progression.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with advanced pancreatic adenocarcinoma.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological or cytological diagnosis of pancreatic adenocarcinoma, confirmed at&#xD;
             MSKCC, AJCC stage IV disease at time of enrollment.&#xD;
&#xD;
          -  Patient planning to receive treatment with FOLFIRINOX or gem/nab-P chemotherapy, with&#xD;
             or without investigational agents.&#xD;
&#xD;
          -  Prior surgery, chemotherapy and/or radiation therapy for AJCC Stage I-III pancreatic&#xD;
             adenocarcinoma is permitted.&#xD;
&#xD;
          -  ECOG performance status 0-2.&#xD;
&#xD;
          -  A minimum age of 18 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior chemotherapy for AJCC stage IV pancreatic adenocarcinoma&#xD;
&#xD;
          -  Known to be HIV positive on antiretroviral therapy&#xD;
&#xD;
          -  Prior organ allograft&#xD;
&#xD;
          -  Any medical or psychiatric condition that may interfere with the ability to comply&#xD;
             with protocol procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center Basking Ridge</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <zip>07920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center @ Suffolk</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Westchester</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Nassau</name>
      <address>
        <city>Uniondale</city>
        <state>New York</state>
        <zip>11553</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>June 29, 2023</last_update_submitted>
  <last_update_submitted_qc>June 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stage IV Pancreatic Cancer</keyword>
  <keyword>FOLFIRINOX</keyword>
  <keyword>gem/nab-P chemotherapy</keyword>
  <keyword>17-042</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/NCT03033927
org study id: 17-042
nct id: NCT03033927
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this phase II study is to develop a test to predict response of pancreatic
      cancer to different chemotherapy regimens.
observational model: Cohort
time perspective: Prospective
measure: Progression Free Survival
time frame: 36 months
description: in patients receiving frontline therapy predicted to be effective versus ineffective based on CTC PGx analysis
arm group label: Participants with Stage IV Pancreatic Cancer
intervention type: Diagnostic Test
intervention name: CTC isolocation and analysis
description: Circulating tumorigenic cell (CTC) isolation and enrichment will be performed using a proprietary invasion assay.
arm group label: Participants with Stage IV Pancreatic Cancer
Sodium heparin tube collections will be performed at baseline, at each restaging CT scan and
      at time of first disease progression. K3-EDTA tubes will be collected at baseline and at
      disease progression.

      In patients who are planning an EGD for the purpose of obtaining a tumor biopsy, portal vein
      sampling will be offered. Under EUS guidance, a 19-gauge EUS fine needle will be advanced
      transhepatically into the portal vein and as many as four 7.5 mL K3-EDTA samples of blood
      will be aspirated, as previously described. Research biopsy will be performed at baseline
      and, if feasible, at disease progression.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.mskcc.org
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms