<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/NCT02206360</url>
  </required_header>
  <id_info>
    <org_study_id>WPH 1401</org_study_id>
    <nct_id>NCT02206360</nct_id>
  </id_info>
  <brief_title>Pancreatic Cancer Early Detection Program</brief_title>
  <acronym>PCEDP</acronym>
  <official_title>Observational Study to Analyze the Outcomes of Subjects Who - Based Upon Their Sufficiently Elevated Risk for the Development of Pancreatic Adenocarcinoma- Elect to Undergo Early Detection Testing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>White Plains Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>White Plains Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Early detection testing is recommended for individuals at elevated risk for the development&#xD;
      of Pancreatic Cancer. This Protocol will define sufficiently elevated risk as either equal to&#xD;
      or greater than five times the general population risk, or five times the average risk (1.5%)&#xD;
      of developing pancreatic cancer by age 70; that is a 7.5% lifetime risk. Our inclusion&#xD;
      criteria has a strong focus on the risk for pancreatic cancer imparted by the presence of&#xD;
      hereditary cancer genes, as well as by family history. Enrolled subjects will undergo&#xD;
      Endoscopic Ultrasound (EUS) alternating with Magnetic Resonance Imaging (MRI), every six to&#xD;
      12 months, for up to 5 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Interested individuals can be referred by physicians, or by family or friends.&#xD;
&#xD;
      Individuals are informed that the purpose of this study is to collect outcome data following&#xD;
      early detection testing based upon our criteria for elevated risk.&#xD;
&#xD;
      Consent is obtained by any of the co-investigators. Consent is obtained for the primary&#xD;
      PCEDP, and also obtained to allow for data to be used by our Cancer Program.&#xD;
&#xD;
      We have a weekly review of all calls made and of all enrollments.&#xD;
&#xD;
      We have a monthly meeting to review all proceeding regarding the study.&#xD;
&#xD;
      Our IRB routinely reviews the proceedings of the study&#xD;
&#xD;
      Our institution has a monthly Clinical research Committee meeting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Anticipated">March 2024</completion_date>
  <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Premalignant or malignant pancreatic conditions found with alternating EUS and MRI testing.</measure>
    <time_frame>5 years</time_frame>
    <description>Number of Participants with Premalignant or Malignant Pancreatic Conditions, as a Measure of Safety and Efficacy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical outcomes which occur as a result of this Protocol</measure>
    <time_frame>5 years</time_frame>
    <description>Prospective collection and reporting of any malignant conditions which occur as a result of this Protocol, including from surgery, or other testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications of any interventions as a result of this Protocol</measure>
    <time_frame>5 years</time_frame>
    <description>Prospective collection and reporting of any complications that may be associated with early detection testing, including hospitalization, disability, and death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-Pancreatic cancers diagnosed while on this protocol</measure>
    <time_frame>5 years</time_frame>
    <description>Prospective collection and reporting of non-pancreatic cancers detected during this Protocol, including pancreatic cysts.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Pancreatic Cancer</condition>
  <condition>Pancreas Cancer</condition>
  <condition>Pancreatic Adenocarcinoma</condition>
  <condition>Familial Pancreatic Cancer</condition>
  <condition>BRCA 1/2</condition>
  <condition>HNPCC</condition>
  <condition>Lynch Syndrome</condition>
  <condition>Hereditary Pancreatitis</condition>
  <condition>FAMMM</condition>
  <condition>Familial Atypical Multiple Mole Melanoma</condition>
  <condition>Peutz Jeghers Syndrome</condition>
  <arm_group>
    <arm_group_label>Individuals at elevated risk for pancreatic cancer</arm_group_label>
    <description>Individuals with an elevated risk of developing pancreatic cancer as either equal to or greater than five times the general population risk, or five times the average risk (1.5%) of developing pancreatic cancer by age 70; that is a 7.5% lifetime risk.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic Ultrasound</intervention_name>
    <arm_group_label>Individuals at elevated risk for pancreatic cancer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Magnetic Resonance Imaging (MRI)</intervention_name>
    <arm_group_label>Individuals at elevated risk for pancreatic cancer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals aged 18 and older, who carry sufficiently elevated risk for the development of&#xD;
        pancreatic cancer, numerically defined as over (or near) 5 times the general population&#xD;
        risk, as determined by their personal, familial, or genetic history.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: Any of the following:&#xD;
&#xD;
          1. Known carrier of either the BRCA2 or CDKN2A mutation;&#xD;
&#xD;
          2. Known carrier of any of the following mutations (BRCA1, MLH1, MSH2, PMS2, MSH6, EPCAM&#xD;
             , P53, PALB2, APC, or ATM) PLUS first or second degree relative affected with&#xD;
             pancreatic cancer;&#xD;
&#xD;
          3. Individual with Peutz-Jeghers Syndrome;&#xD;
&#xD;
          4. Familial Pancreatic Cancer, defined as at least two affected relatives with Pancreatic&#xD;
             Cancer, who are first degree relatives with each other, and at least one of those&#xD;
             affected must be first degree relative to the study subject;&#xD;
&#xD;
          5. Both parents affected, any age:&#xD;
&#xD;
          6. Any first degree relative diagnosed with pancreatic cancer under age 50;&#xD;
&#xD;
          7. Chronic Pancreatitis Syndrome, defined by either PRSS1 or SPINK1 mutations AND&#xD;
             appropriate clinical and family history&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any medical condition that contraindicates endoscopy or biopsy&#xD;
&#xD;
          2. Any medical condition that contraindicates MRI&#xD;
&#xD;
          3. Status post partial or complete resection of the pancreas&#xD;
&#xD;
          4. History of pancreatic cancer, either endocrine or exocrine&#xD;
&#xD;
          5. Clinical suspicion of pancreatic cancer, or any previous radiographic or histologic&#xD;
             diagnosis of a pre-malignant finding, including IPMN (Intraductal papillary mucinous&#xD;
             neoplasm) and PanIN (Pancreatic intraepithelial Neoplasm).&#xD;
&#xD;
          6. diagnosis of dementia&#xD;
&#xD;
          7. Uncontrolled, current illness&#xD;
&#xD;
          8. Renal insufficiency with serum creatinine greater than 2.0 mg/dl&#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_contact>
    <last_name>Jessica Maldonado, NP</last_name>
    <phone>914-849-2530</phone>
    <email>JMaldonado1@wphospital.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Joshua P Raff, MD</last_name>
    <phone>914-849-7600</phone>
    <email>jraff@wphospital.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>White Plains Hospital</name>
      <address>
        <city>White Plains</city>
        <state>New York</state>
        <zip>10601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jessica Maldonado, NP</last_name>
      <phone>914-849-2530</phone>
      <email>JMaldonado1@wphospital.org</email>
    </contact>
    <investigator>
      <last_name>Joshua P Raff, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>July 6, 2023</last_update_submitted>
  <last_update_submitted_qc>July 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>White Plains Hospital</investigator_affiliation>
    <investigator_full_name>Joshua Raff, MD</investigator_full_name>
    <investigator_title>Director, Digestive Cancer Program, Center for Cancer Care</investigator_title>
  </responsible_party>
  <keyword>Pancreatic Cancer</keyword>
  <keyword>Pancreatic Cancer Screening</keyword>
  <keyword>Pancreas Cancer</keyword>
  <keyword>Pancreatic Adenocarcinoma</keyword>
  <keyword>Pancreatic Adenocarcinoma screening</keyword>
  <keyword>Familial Pancreatic Cancer</keyword>
  <keyword>BRCA 1/2</keyword>
  <keyword>HNPCC</keyword>
  <keyword>Lynch Syndrome</keyword>
  <keyword>Hereditary Pancreatitis</keyword>
  <keyword>FAMMM</keyword>
  <keyword>Familial atypical multiple mole melanoma</keyword>
  <keyword>Peutz Jeghers Syndrome</keyword>
  <keyword>MRI</keyword>
  <keyword>Magnetic Resonance Imaging</keyword>
  <keyword>EUS</keyword>
  <keyword>Endoscopic Ultrasound</keyword>
  <keyword>Early detection</keyword>
  <keyword>Screening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms, Hereditary Nonpolyposis</mesh_term>
    <mesh_term>Peutz-Jeghers Syndrome</mesh_term>
    <mesh_term>Dysplastic Nevus Syndrome</mesh_term>
    <mesh_term>Pancreatitis</mesh_term>
    <mesh_term>Pancreatitis, Chronic</mesh_term>
    <mesh_term>Syndrome</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/NCT02206360
org study id: WPH 1401
nct id: NCT02206360
lead sponsor: 
has dmc: Yes
Early detection testing is recommended for individuals at elevated risk for the development
      of Pancreatic Cancer. This Protocol will define sufficiently elevated risk as either equal to
      or greater than five times the general population risk, or five times the average risk (1.5%)
      of developing pancreatic cancer by age 70; that is a 7.5% lifetime risk. Our inclusion
      criteria has a strong focus on the risk for pancreatic cancer imparted by the presence of
      hereditary cancer genes, as well as by family history. Enrolled subjects will undergo
      Endoscopic Ultrasound (EUS) alternating with Magnetic Resonance Imaging (MRI), every six to
      12 months, for up to 5 years.
Interested individuals can be referred by physicians, or by family or friends.

      Individuals are informed that the purpose of this study is to collect outcome data following
      early detection testing based upon our criteria for elevated risk.

      Consent is obtained by any of the co-investigators. Consent is obtained for the primary
      PCEDP, and also obtained to allow for data to be used by our Cancer Program.

      We have a weekly review of all calls made and of all enrollments.

      We have a monthly meeting to review all proceeding regarding the study.

      Our IRB routinely reviews the proceedings of the study

      Our institution has a monthly Clinical research Committee meeting.
observational model: Other
time perspective: Prospective
measure: Premalignant or malignant pancreatic conditions found with alternating EUS and MRI testing.
time frame: 5 years
description: Number of Participants with Premalignant or Malignant Pancreatic Conditions, as a Measure of Safety and Efficacy
measure: Clinical outcomes which occur as a result of this Protocol
time frame: 5 years
description: Prospective collection and reporting of any malignant conditions which occur as a result of this Protocol, including from surgery, or other testing.
measure: Complications of any interventions as a result of this Protocol
time frame: 5 years
description: Prospective collection and reporting of any complications that may be associated with early detection testing, including hospitalization, disability, and death.
measure: Non-Pancreatic cancers diagnosed while on this protocol
time frame: 5 years
description: Prospective collection and reporting of non-pancreatic cancers detected during this Protocol, including pancreatic cysts.
arm group label: Individuals at elevated risk for pancreatic cancer
description: Individuals with an elevated risk of developing pancreatic cancer as either equal to or greater than five times the general population risk, or five times the average risk (1.5%) of developing pancreatic cancer by age 70; that is a 7.5% lifetime risk.
intervention type: Procedure
intervention name: Endoscopic Ultrasound
arm group label: Individuals at elevated risk for pancreatic cancer
intervention type: Procedure
intervention name: Magnetic Resonance Imaging (MRI)
arm group label: Individuals at elevated risk for pancreatic cancer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jessica Maldonado, NP
phone: 914-849-2530
email: JMaldonado1@wphospital.org
last name: Joshua P Raff, MD
phone: 914-849-7600
email: jraff@wphospital.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: White Plains Hospital
investigator full name: Joshua Raff, MD
investigator title: Director, Digestive Cancer Program, Center for Cancer Care
mesh term: Melanoma
mesh term: Adenocarcinoma
mesh term: Pancreatic Neoplasms
mesh term: Colorectal Neoplasms, Hereditary Nonpolyposis
mesh term: Peutz-Jeghers Syndrome
mesh term: Dysplastic Nevus Syndrome
mesh term: Pancreatitis
mesh term: Pancreatitis, Chronic
mesh term: Syndrome