<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/NCT04476537</url>
  </required_header>
  <id_info>
    <org_study_id>AAAR6703</org_study_id>
    <nct_id>NCT04476537</nct_id>
  </id_info>
  <brief_title>RNA Precision Oncology in Advanced Pancreatic Cancer</brief_title>
  <acronym>HIPPOCRATES</acronym>
  <official_title>Identification of Personalized Treatment Utilizing Master Regulator Gene Targets in Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall objective of this project is to determinate the feasibility of administering&#xD;
      personalized therapy to subjects with advanced pancreatic cancer utilizing the novel&#xD;
      OncoTreat platform. The primary objective of this study is to assess the feasibility of&#xD;
      implementing the OncoTreat framework in patients with newly diagnosed, untreated metastatic&#xD;
      pancreatic adenocarcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pancreatic ductal adenocarcinoma (PDA) is a major health problem in the United States and&#xD;
      throughout the world. Pancreatic ductal adenocarcinoma (PDA) has the worst prognosis of any&#xD;
      major malignancy in the United States and, unlike other common cancers, annual deaths from&#xD;
      PDA are rising. During 2017, it is estimated that 53,670 people were diagnosed with PDA and&#xD;
      approximately 43,090 people died from PDA in the U.S. Despite recent advances, cytotoxic&#xD;
      chemotherapy for PDA has been disappointing with response rates of 20-30% for the most active&#xD;
      regimens and little activity for targeted therapies. Even among the small subset of patients&#xD;
      who are suitable for surgical resection at the time of diagnosis, complete resection is&#xD;
      followed by recurrence in &gt;90% of patients without further systemic therapy, with a median&#xD;
      time to recurrence of 6.9 months. Thus all PDA patients require systemic chemotherapy and&#xD;
      more effective regimens are urgently needed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 10, 2018</start_date>
  <completion_date type="Anticipated">May 2023</completion_date>
  <primary_completion_date type="Anticipated">May 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants assigned therapy with OncoTreat</measure>
    <time_frame>36 months</time_frame>
    <description>The primary outcome of the study is whether a subject is assigned a therapy that they are able to begin on Part 2 of this study. Assignment of therapy is based on results from OncoTreat analysis and recommendations of the Precision Medicine Tumor Board (PMTB) which included assessment of availability and expected toxicity of identified agents.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals who meet the eligibility criteria based on their provided tissue sample will be followed by the investigators to obtain medical information every 4 weeks. This follow-up will consist of a review of medical records, contact with the participant's treating physician, or personal contact between the participant and the investigators at Columbia University Irving Medical Center (CUIMC). During the study, their tumor tissue will be evaluated to identify medications that may help treat the cancer. The results of these tests will be reviewed by experts on a Precision Medicine Tumor Board (PMTB) and these experts may recommend a specific treatment to the participant or participant's physician.These participants will continue to be followed until death or withdrawal of consent from the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observation Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Individuals who do not meet the eligibility criteria based on their provided tissue sample will be provided follow-up with their treating physicians up to every 4 weeks to gather clinical information related to their disease.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OncoTreat</intervention_name>
    <description>OncoTreat is a computational pipeline that begins with a tumor expression profile and ends with a list of several candidate regimens.</description>
    <arm_group_label>Intervention Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be willing and able to provide written informed consent for the trial.&#xD;
&#xD;
          -  Age ≥18 years of age on day of signing informed consent.&#xD;
&#xD;
          -  Have histologically or cytologically confirmed diagnosis of pancreatic ductal&#xD;
             adenocarcinoma or be willing to undergo a biopsy with confirmed pathology prior to&#xD;
             starting therapy.&#xD;
&#xD;
          -  Have untreated disease that is unresectable due to being metastatic or locally&#xD;
             advanced without potential of surgery as assessed by the treating physician.&#xD;
&#xD;
          -  Subjects who have documented disease recurrence greater than 6 months after completing&#xD;
             neoadjuvant or adjuvant chemotherapy for limited disease will be eligible for the&#xD;
             study.&#xD;
&#xD;
          -  Have a predicted life expectancy of greater than 6 months.&#xD;
&#xD;
          -  Subjects must have a plan to obtain a new core biopsy of a primary and/or metastatic&#xD;
             lesion planned as part of routine care for which consent is obtained separately or (b)&#xD;
             consent to be biopsied to satisfy the tissue requirements of this protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Has previously received neoadjvuant or adjuvant chemotherapy for pancreatic cancer unless&#xD;
        greater than 6 months has passed since completion of adjuvant or neoadjuvant chemotherapy&#xD;
        and initiation of therapy for recurrent or metastatic disease.&#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>Rachael A. Safyan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Research Nurse Navigator</last_name>
    <phone>(212) 342-5162</phone>
    <email>cancerclinicaltrials@cumc.columbia.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Columbia University Irving Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rachael A. Safyan, MD</last_name>
      <phone>646-317-2321</phone>
      <email>rs2263@cumc.columbia.edu</email>
    </contact>
    <investigator>
      <last_name>Rachael A. Safyan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>November 29, 2022</last_update_submitted>
  <last_update_submitted_qc>November 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Gulam Manji</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Pancreatic ductal adenocarcinoma (PDA)</keyword>
  <keyword>Precision medicine</keyword>
  <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>Undecided</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/NCT04476537
org study id: AAAR6703
nct id: NCT04476537
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The overall objective of this project is to determinate the feasibility of administering
      personalized therapy to subjects with advanced pancreatic cancer utilizing the novel
      OncoTreat platform. The primary objective of this study is to assess the feasibility of
      implementing the OncoTreat framework in patients with newly diagnosed, untreated metastatic
      pancreatic adenocarcinoma.
Pancreatic ductal adenocarcinoma (PDA) is a major health problem in the United States and
      throughout the world. Pancreatic ductal adenocarcinoma (PDA) has the worst prognosis of any
      major malignancy in the United States and, unlike other common cancers, annual deaths from
      PDA are rising. During 2017, it is estimated that 53,670 people were diagnosed with PDA and
      approximately 43,090 people died from PDA in the U.S. Despite recent advances, cytotoxic
      chemotherapy for PDA has been disappointing with response rates of 20-30% for the most active
      regimens and little activity for targeted therapies. Even among the small subset of patients
      who are suitable for surgical resection at the time of diagnosis, complete resection is
      followed by recurrence in >90% of patients without further systemic therapy, with a median
      time to recurrence of 6.9 months. Thus all PDA patients require systemic chemotherapy and
      more effective regimens are urgently needed.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of participants assigned therapy with OncoTreat
time frame: 36 months
description: The primary outcome of the study is whether a subject is assigned a therapy that they are able to begin on Part 2 of this study. Assignment of therapy is based on results from OncoTreat analysis and recommendations of the Precision Medicine Tumor Board (PMTB) which included assessment of availability and expected toxicity of identified agents.
arm group label: Intervention Arm
arm group type: Experimental
description: Individuals who meet the eligibility criteria based on their provided tissue sample will be followed by the investigators to obtain medical information every 4 weeks. This follow-up will consist of a review of medical records, contact with the participant's treating physician, or personal contact between the participant and the investigators at Columbia University Irving Medical Center (CUIMC). During the study, their tumor tissue will be evaluated to identify medications that may help treat the cancer. The results of these tests will be reviewed by experts on a Precision Medicine Tumor Board (PMTB) and these experts may recommend a specific treatment to the participant or participant's physician.These participants will continue to be followed until death or withdrawal of consent from the study.
arm group label: Observation Arm
arm group type: No Intervention
description: Individuals who do not meet the eligibility criteria based on their provided tissue sample will be provided follow-up with their treating physicians up to every 4 weeks to gather clinical information related to their disease.
intervention type: Device
intervention name: OncoTreat
description: OncoTreat is a computational pipeline that begins with a tumor expression profile and ends with a list of several candidate regimens.
arm group label: Intervention Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rachael A. Safyan, MD
role: Principal Investigator
affiliation: Columbia University
last name: Research Nurse Navigator
phone: (212) 342-5162
email: cancerclinicaltrials@cumc.columbia.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Gulam Manji
investigator title: Associate Professor of Medicine
mesh term: Pancreatic Neoplasms
sharing ipd: Undecided