<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/NCT03250078</url>
  </required_header>
  <id_info>
    <org_study_id>16-17</org_study_id>
    <nct_id>NCT03250078</nct_id>
  </id_info>
  <brief_title>A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals</brief_title>
  <official_title>A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals</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>Yes</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>
      The main goal of this study is to screen and detect pancreatic cancer and precursor lesions&#xD;
      in individuals with a strong family history or genetic predisposition to pancreatic cancer.&#xD;
      Magnetic Resonance Imaging and Magnetic cholangiopancreatography (MRI/MRCP) will be utilized&#xD;
      to screen for early stage pancreatic cancer or precursor lesions. Participants will be asked&#xD;
      to donate a blood sample at specific intervals for the creation of a bio-bank necessary for&#xD;
      the development of a blood based screening test for Pancreatic Cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Individuals 50 years of age and older who have a family history of pancreatic cancer will be&#xD;
      recruited through the offices of primary care physicians and endocrinologists. Those meeting&#xD;
      initial criteria will meet with a research APRN and will undergo a secondary screen to&#xD;
      determine eligibility. Individuals enrolled in the study will undergo a five-minute&#xD;
      psychological survey and donation of a blood sample for bio-bank analysis every 6 months for&#xD;
      3 years. MRI will be performed annually for 3 years (4 in total). Any abnormalities on MRI&#xD;
      will be reviewed by a multi-disciplinary tumor board and discussed with the participant. The&#xD;
      costs of MRI will be covered by the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">November 2026</completion_date>
  <primary_completion_date type="Anticipated">November 2026</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>Early Stage Pancreatic Cancer or Precursor Lesions</measure>
    <time_frame>Through study completion, up to 3 years</time_frame>
    <description>Incidence of Pancreatic Cancer or precursor lesions within a population of individuals with a strong family history of pancreatic cancer or known genetic mutation compared to the expected incidence in the general population.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serial Pancreatic MRI Screening</measure>
    <time_frame>Through study completion, up to 3 years</time_frame>
    <description>Utility of MRI as a screening tool for Pancreatic Cancer in the study population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Bio-bank</measure>
    <time_frame>Through study completion, up to 3 years</time_frame>
    <description>Banking serum from participants to isolate circulating exosomes and circulating tumor DNA.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Pancreatic Neoplasms</condition>
  <arm_group>
    <arm_group_label>FAMILIAL PANCREATIC CANCER and/or GENE MUTATION</arm_group_label>
    <description>An inherited genetic syndrome associated with Pancreatic Cancer and/or with a strong family history of Pancreatic Cancer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MRI/MRCP</intervention_name>
    <description>An MRI/MRCP plus IV gadolinium contrast with high resolution imaging of the pancreas will be performed annually</description>
    <arm_group_label>FAMILIAL PANCREATIC CANCER and/or GENE MUTATION</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        50-90 years of age. Strong family history of pancreatic cancer/ known genetic mutation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Registration-Inclusion Criteria for FAMILIAL PANCREATIC CANCER (FPC) and those with a&#xD;
        BRCA1, BRCA2, LYNCH SYNDROME, ATM, PALB2, CDKN2A, or related gene mutation (one of the&#xD;
        following is required for questions 1-3)&#xD;
&#xD;
          1. For FPC: The individual has at least 2 first-degree relatives (FDR) with PC.&#xD;
&#xD;
          2. For FPC: The individual has at least 3 first-, second-, or third-degree relatives with&#xD;
             PC with at least 1 PC in a FDR.&#xD;
&#xD;
          3. The individual is a known mutation carrier of BRCA1, BRCA2, MLH1, MSH2, MSH6, or PMS2,&#xD;
             ATM, PALB2, CDKN2A, or similar high-risk gene mutation and has at least 1 first- or&#xD;
             second-degree relative with PC.&#xD;
&#xD;
          4. The individual is at least 50 years old or 10 years younger than the youngest relative&#xD;
             with PC.&#xD;
&#xD;
          5. Family and genetic history confirmed by genetics counselor at WCHN.&#xD;
&#xD;
          6. ECOG Performance Status of 0-1.&#xD;
&#xD;
          7. No known contraindications to MRI examination or gadolinium contrast.&#xD;
&#xD;
          8. Willing to undergo MRI and screening for metal implants or metal injury.&#xD;
&#xD;
          9. Prior BUN and Cr&#xD;
&#xD;
         10. Estimated GFR (eGFR) must be greater than 30 mL/min.&#xD;
&#xD;
         11. Ability to provide informed consent.&#xD;
&#xD;
         12. Willing to return to study site for all study assessments.&#xD;
&#xD;
        Registration-Exclusion Criteria:&#xD;
&#xD;
          1. Prior history of pancreatic cancer.&#xD;
&#xD;
          2. Presence of metastatic cancer or cancer requiring adjuvant chemotherapy within the&#xD;
             past 5 years.&#xD;
&#xD;
          3. Received chemotherapy within the past 6 months. (Hormonal therapy is allowable if the&#xD;
             disease free interval is at least 5 years).&#xD;
&#xD;
          4. Hereditary pancreatitis.&#xD;
&#xD;
          5. eGFR &lt; 30 mL/min&#xD;
&#xD;
          6. Contraindication to MRI examination or gadolinium contrast.&#xD;
&#xD;
          7. Pregnant or nursing women.&#xD;
&#xD;
          8. Co-morbid illnesses or other concurrent disease which, in the judgment of the&#xD;
             clinicians obtaining informed consent, would make the participant inappropriate for&#xD;
             entry into this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</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>Tammy Lo, APRN</last_name>
    <email>Tammy.Lo@nuvancehealth.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pramila Krumholtz, RN</last_name>
    <email>Pramila.Krumholtz@nuvancehealth.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Western Connecticut Health Network</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>
    <contact_backup>
      <last_name>Pramila Krumholtz, RN</last_name>
      <phone>203-739-7997</phone>
      <email>Pramila.Krumholtz@nuvancehealth.org</email>
    </contact_backup>
    <investigator>
      <last_name>Richard Frank, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.nuvancehealth.org/about-us/research-and-innovation/cancer-research/pancreatic-cancer-research</url>
    <description>An overview pancreatic cancer research at Nuvance Health</description>
  </link>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</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 13, 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, Cancer Research</investigator_title>
  </responsible_party>
  <keyword>Pancreas</keyword>
  <keyword>Cancer</keyword>
  <keyword>MRI</keyword>
  <keyword>BRCA</keyword>
  <keyword>Early Detection</keyword>
  <keyword>Genetics</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 individual 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/NCT03250078
org study id: 16-17
nct id: NCT03250078
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The main goal of this study is to screen and detect pancreatic cancer and precursor lesions
      in individuals with a strong family history or genetic predisposition to pancreatic cancer.
      Magnetic Resonance Imaging and Magnetic cholangiopancreatography (MRI/MRCP) will be utilized
      to screen for early stage pancreatic cancer or precursor lesions. Participants will be asked
      to donate a blood sample at specific intervals for the creation of a bio-bank necessary for
      the development of a blood based screening test for Pancreatic Cancer.
Individuals 50 years of age and older who have a family history of pancreatic cancer will be
      recruited through the offices of primary care physicians and endocrinologists. Those meeting
      initial criteria will meet with a research APRN and will undergo a secondary screen to
      determine eligibility. Individuals enrolled in the study will undergo a five-minute
      psychological survey and donation of a blood sample for bio-bank analysis every 6 months for
      3 years. MRI will be performed annually for 3 years (4 in total). Any abnormalities on MRI
      will be reviewed by a multi-disciplinary tumor board and discussed with the participant. The
      costs of MRI will be covered by the study.
observational model: Cohort
time perspective: Prospective
measure: Early Stage Pancreatic Cancer or Precursor Lesions
time frame: Through study completion, up to 3 years
description: Incidence of Pancreatic Cancer or precursor lesions within a population of individuals with a strong family history of pancreatic cancer or known genetic mutation compared to the expected incidence in the general population.
measure: Serial Pancreatic MRI Screening
time frame: Through study completion, up to 3 years
description: Utility of MRI as a screening tool for Pancreatic Cancer in the study population.
measure: Serum Bio-bank
time frame: Through study completion, up to 3 years
description: Banking serum from participants to isolate circulating exosomes and circulating tumor DNA.
arm group label: FAMILIAL PANCREATIC CANCER and/or GENE MUTATION
description: An inherited genetic syndrome associated with Pancreatic Cancer and/or with a strong family history of Pancreatic Cancer.
intervention type: Diagnostic Test
intervention name: MRI/MRCP
description: An MRI/MRCP plus IV gadolinium contrast with high resolution imaging of the pancreas will be performed annually
arm group label: FAMILIAL PANCREATIC CANCER and/or GENE MUTATION
Serum sample
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 90 Years
healthy volunteers: No
last name: Richard Frank, MD
role: Principal Investigator
affiliation: Nuvance Health
last name: Tammy Lo, APRN
email: Tammy.Lo@nuvancehealth.org
last name: Pramila Krumholtz, RN
email: Pramila.Krumholtz@nuvancehealth.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
url: https://www.nuvancehealth.org/about-us/research-and-innovation/cancer-research/pancreatic-cancer-research
description: An overview pancreatic cancer research at Nuvance Health
responsible party type: Principal Investigator
investigator affiliation: Nuvance Health
investigator full name: Richard Frank
investigator title: Director, Cancer Research
mesh term: Pancreatic Neoplasms
sharing ipd: Yes
ipd description: De-identified individual 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.