<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/NCT04406831</url>
  </required_header>
  <id_info>
    <org_study_id>15-10</org_study_id>
    <nct_id>NCT04406831</nct_id>
  </id_info>
  <brief_title>The Role of MicroRNA in the Diagnosis, Prognosis and Response to Treatment in Pancreatic Cancer</brief_title>
  <official_title>The Role of MicroRNA in the Diagnosis, Prognosis and Response to Treatment in Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nuvance Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nuvance Health</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>
      Aberrant miRNA production has been linked to a wide range of human cancers and shown to play&#xD;
      important roles in their genesis and growth. These miRNA can be detected in the blood and&#xD;
      tumors of patients with cancer. The investigators hypothesize that the detection of certain&#xD;
      miRNAs present in the blood/serum of patients with pancreatic cancer may be important to the&#xD;
      early diagnosis of the disease. Furthermore, the investigators hypothesize that miRNA&#xD;
      detection in PC patients will yield prognostic information and help predict the response to&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific aims of the study include:&#xD;
&#xD;
        1. To obtain serum samples from patients with newly diagnosed pancreatic cancer at baseline&#xD;
           before treatment and monthly throughout treatment.&#xD;
&#xD;
        2. To analyze the miRNA profiles present at each time point.&#xD;
&#xD;
        3. To determine miRNAs that may distinguish pancreatic patients from unaffected&#xD;
           individuals. This could be developed into a diagnostic test.&#xD;
&#xD;
        4. To determine miRNAs whose levels correlate with treatment response, both in patients&#xD;
           with and without elevations in the serum tumor marker CA 19-9.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 2015</start_date>
  <completion_date type="Anticipated">April 2027</completion_date>
  <primary_completion_date type="Anticipated">April 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Analysis of miRNA profile</measure>
    <time_frame>Through study completion, up to 5 years</time_frame>
    <description>Analyze the miRNA profiles present at each time point.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PCR miRNA validation</measure>
    <time_frame>Through study completion, up to 5 years</time_frame>
    <description>Determine miRNAs that may distinguish pancreatic patients from unaffected individuals. This could be developed into a diagnostic test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>miRNA PCR expression</measure>
    <time_frame>Through study completion, up to 5 years</time_frame>
    <description>Determine miRNAs whose levels correlate with treatment response, both in patients with and without elevations in the serum tumor marker CA 19-9.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Pancreatic Cancer Stage III</condition>
  <condition>Pancreatic Cancer Stage IV</condition>
  <condition>Pancreatic Ductal Adenocarcinoma</condition>
  <condition>Pancreatic Neoplasms</condition>
  <arm_group>
    <arm_group_label>New Unresectable Pancreatic Cancer</arm_group_label>
    <description>Individuals with biopsy-proven adenocarcinoma of the pancreas, classified as locally advanced or metastatic disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Healthy individuals without cancer diagnoses to provide reference microRNA</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood draw</intervention_name>
    <description>Individuals in the unresectable pancreatic cancer group will receive monthly blood draws. Individuals in the control group will receive one blood draw</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>New Unresectable Pancreatic Cancer</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum Samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals with new diagnoses of unresectable pancreatic cancer, or recurrent pancreatic&#xD;
        cancer following a Whipple procedure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have biopsy proven adenocarcinoma of the pancreas&#xD;
&#xD;
          -  Have initially inoperable disease, classified as either locally advanced or metastatic&#xD;
             disease&#xD;
&#xD;
               -  Recurrent disease after a Whipple procedure is allowed&#xD;
&#xD;
               -  Patients who are able to undergo resection after neoadjuvant therapy will&#xD;
                  continue to be followed after resection&#xD;
&#xD;
          -  Have radiographically measurable disease&#xD;
&#xD;
          -  Have an ECOG performance status of &lt; 2&#xD;
&#xD;
          -  Be willing to contribute the required information and specimens&#xD;
&#xD;
          -  Provide written signed consent to participate&#xD;
&#xD;
          -  Be eligible to receive multi-agent chemotherapy for the first line treatment of&#xD;
             pancreatic cancer&#xD;
&#xD;
          -  Have a predicted life expectancy of at least 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having received prior anti-cancer treatments for metastatic pancreatic cancer&#xD;
&#xD;
          -  Concurrently receiving systemic therapy for another cancer except androgen deprivation&#xD;
             therapy for stable/controlled prostate cancer&#xD;
&#xD;
          -  Presence of other active cancer except for: adequately treated local basal or squamous&#xD;
             cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer,&#xD;
             asymptomatic prostate cancer without known metastatic disease and with no requirement&#xD;
             for therapy or requiring only hormonal therapy and with normal prostate-specific&#xD;
             antigen for &gt;1 year prior to start of trial. Other adequately treated Stage 1 or 2&#xD;
             cancer currently in complete remission, or any other cancer that has been in complete&#xD;
             remission for &gt; 5 years is allowable&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Frank, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nuvance Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pramila Krumholtz, RN</last_name>
    <email>pramila.krumholtz@nuvancehealth.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tammy Lo, MSN</last_name>
    <email>tammy.lo@nuvancehealth.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nuvance Health</name>
      <address>
        <city>Norwalk</city>
        <state>Connecticut</state>
        <zip>06856</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tammy Lo, APRN</last_name>
      <phone>203-855-3551</phone>
      <email>Tammy.Lo@nuvancehealth.org</email>
    </contact>
    <investigator>
      <last_name>Richard Frank, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>October 10, 2022</last_update_submitted>
  <last_update_submitted_qc>October 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nuvance Health</investigator_affiliation>
    <investigator_full_name>Richard Frank</investigator_full_name>
    <investigator_title>Director of Cancer Research</investigator_title>
  </responsible_party>
  <keyword>Pancreas</keyword>
  <keyword>Cancer</keyword>
  <keyword>Biomarker</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>Yes</sharing_ipd>
    <ipd_description>De-identified participant data for all primary and secondary outcome measures will be made available</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data will be available within 6 months of study completion</ipd_time_frame>
    <ipd_access_criteria>Data access requests will be reviewed on an individual basis post submission. Requestors may be required to sign a data access agreement</ipd_access_criteria>
  </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/NCT04406831
org study id: 15-10
nct id: NCT04406831
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aberrant miRNA production has been linked to a wide range of human cancers and shown to play
      important roles in their genesis and growth. These miRNA can be detected in the blood and
      tumors of patients with cancer. The investigators hypothesize that the detection of certain
      miRNAs present in the blood/serum of patients with pancreatic cancer may be important to the
      early diagnosis of the disease. Furthermore, the investigators hypothesize that miRNA
      detection in PC patients will yield prognostic information and help predict the response to
      treatment.
Specific aims of the study include:

        1. To obtain serum samples from patients with newly diagnosed pancreatic cancer at baseline
           before treatment and monthly throughout treatment.

        2. To analyze the miRNA profiles present at each time point.

        3. To determine miRNAs that may distinguish pancreatic patients from unaffected
           individuals. This could be developed into a diagnostic test.

        4. To determine miRNAs whose levels correlate with treatment response, both in patients
           with and without elevations in the serum tumor marker CA 19-9.
observational model: Ecologic or Community
time perspective: Prospective
measure: Analysis of miRNA profile
time frame: Through study completion, up to 5 years
description: Analyze the miRNA profiles present at each time point.
measure: PCR miRNA validation
time frame: Through study completion, up to 5 years
description: Determine miRNAs that may distinguish pancreatic patients from unaffected individuals. This could be developed into a diagnostic test.
measure: miRNA PCR expression
time frame: Through study completion, up to 5 years
description: Determine miRNAs whose levels correlate with treatment response, both in patients with and without elevations in the serum tumor marker CA 19-9.
arm group label: New Unresectable Pancreatic Cancer
description: Individuals with biopsy-proven adenocarcinoma of the pancreas, classified as locally advanced or metastatic disease
arm group label: Control
description: Healthy individuals without cancer diagnoses to provide reference microRNA
intervention type: Procedure
intervention name: Blood draw
description: Individuals in the unresectable pancreatic cancer group will receive monthly blood draws. Individuals in the control group will receive one blood draw
arm group label: Control
arm group label: New Unresectable Pancreatic Cancer
Serum Samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Richard Frank, MD
role: Principal Investigator
affiliation: Nuvance Health
last name: Pramila Krumholtz, RN
email: pramila.krumholtz@nuvancehealth.org
last name: Tammy Lo, MSN
email: tammy.lo@nuvancehealth.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Nuvance Health
investigator full name: Richard Frank
investigator title: Director of Cancer Research
mesh term: Pancreatic Neoplasms
sharing ipd: Yes
ipd description: De-identified participant data for all primary and secondary outcome measures will be made available
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data will be available within 6 months of study completion
ipd access criteria: Data access requests will be reviewed on an individual basis post submission. Requestors may be required to sign a data access agreement