<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/NCT04400903</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00021185</org_study_id>
    <secondary_id>NCI-2020-03178</secondary_id>
    <secondary_id>STUDY00021185</secondary_id>
    <secondary_id>R01CA264133</secondary_id>
    <nct_id>NCT04400903</nct_id>
  </id_info>
  <brief_title>Monitoring Heart Rate Variability for the Early Detection of Pancreatic Cancer</brief_title>
  <official_title>A Prospective, Multi-Center Investigational Study of Heart Rate Variability Monitoring for the Early Detection of Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OHSU Knight Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>American Association for Cancer Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>OHSU Knight Cancer Institute</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>
      This study examines heart rate monitoring variability for the early detection of pancreatic&#xD;
      cancer. Pancreatic cancer is a very difficult disease to detect early. This study is being&#xD;
      done to observe the heart rate variability in patients with pancreatic cancer compared to&#xD;
      undiagnosed individuals with increased risk of developing pancreatic cancer. This may help&#xD;
      researchers determine if pancreatic occurrences/recurrences (chance of coming back) can be&#xD;
      detected sooner through monitoring heart rate and activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine whether heart rate variability (HRV) is reduced in patients with pancreatic&#xD;
      ductal adenocarcinoma (PDAC) compared with individuals at increased risk of developing PDAC.&#xD;
      (Stage I) II. To assess the feasibility of long-term compliance using a wearable device.&#xD;
      (Stage II)&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To assess compliance with using a wearable device. (Stage I and II) II. To validate&#xD;
      effectiveness of virtual device training. (Stage I and II) III. To determine whether HRV is&#xD;
      reduced in participants at high-risk of developing PDAC. (Stage II) IV. To characterize&#xD;
      timing and occurrence of PDAC among high-risk without disease. (Stage II) V. To characterize&#xD;
      timing and occurrence of PDAC among participants at high-risk of developing PDAC. (Stage II)&#xD;
&#xD;
      EXPLORATORY OBJECTIVES:&#xD;
&#xD;
      I. To investigate the relationship between changes in HRV relative to sarcopenia-related body&#xD;
      composition characteristics in PDAC patients. (Stage I) II. To investigate the relationship&#xD;
      between the pNN50 HRV measure and PDAC diagnosis. (Stage I and II) III. To compare changes in&#xD;
      sleep biometrics among all participants. (Stage I and II) IV. To evaluate changes in&#xD;
      health-related quality of life assessments among all participants. (Stage I and II) V. To&#xD;
      evaluate participant satisfaction with virtual device instruction.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Participants undergo HRV monitoring using an activity monitor (WHOOP) for a minimum of 5 days&#xD;
      weekly for up to 1 year in patients with newly-diagnosed PDAC and up to 5 years for patients&#xD;
      in high risk group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow accrual&#xD;
  </why_stopped>
  <start_date type="Actual">September 21, 2020</start_date>
  <completion_date type="Actual">September 30, 2022</completion_date>
  <primary_completion_date type="Actual">September 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Magnitude of heart rate variability (HRV) decline (Stage I)</measure>
    <time_frame>Up to 1 year after enrollment</time_frame>
    <description>As measured by root mean square of the successive differences (RMSSD) in pancreatic ductal adenocarcinoma (PDAC) patients and in high-risk participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compliance statistics for wristband use (Stage II)</measure>
    <time_frame>Until onset of PDAC, study withdrawal, or death, whichever occurs first, assessed up to 5 years after enrollment</time_frame>
    <description>Defined as the percentage of days during which data were collected during at least 70% of the hours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compliance statistics for wristband use for all participants (Stage I, II)</measure>
    <time_frame>Up to 6 weeks and 6 months after enrollment and device activation</time_frame>
    <description>Defined as the percentage of days during which data were collected for at least 70% of the hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effectiveness of virtual training (Stage I, II)</measure>
    <time_frame>Up to 1 week after enrollment and device activation</time_frame>
    <description>Defined as the percentage of participants for whom high quality data are available within 3 days of set up. The pattern of missing data, and the percentage of participants able to collect data will be presented graphically. Will also associate the compliance with patient characteristics, regions and seasons to understand what may impact the compliance rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Magnitude of HRV change (Stage II)</measure>
    <time_frame>Up to 5 years post enrollment</time_frame>
    <description>As measured by RMSSD, in participants at high-risk of developing PDAC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of PDAC among high-risk participants (Stage II)</measure>
    <time_frame>Up to 5 years post enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of PDAC diagnosis among high-risk participants who developed PDAC (Stage II)</measure>
    <time_frame>Up to 5 years post enrollment</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">110</enrollment>
  <condition>Pancreatic Ductal Adenocarcinoma</condition>
  <condition>Stage I Pancreatic Cancer AJCC v8</condition>
  <condition>Stage IA Pancreatic Cancer AJCC v8</condition>
  <condition>Stage IB Pancreatic Cancer AJCC v8</condition>
  <arm_group>
    <arm_group_label>Observational (HRV monitoring, questionnaire)</arm_group_label>
    <description>Participants undergo HRV monitoring using an activity monitor (WHOOP) for a minimum of 5 days weekly for up to 1 year in patients with newly-diagnosed PDAC and up to 5 years for patients in high risk group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Activity Monitor</intervention_name>
    <description>Undergo HRV monitoring via WHOOP device</description>
    <arm_group_label>Observational (HRV monitoring, questionnaire)</arm_group_label>
    <other_name>Activity Tracker</other_name>
    <other_name>Activity Tracker Device</other_name>
    <other_name>Physical Activity Measuring Device</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Observational (HRV monitoring, questionnaire)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Complete questionnaires</description>
    <arm_group_label>Observational (HRV monitoring, questionnaire)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with PDAC and participants at high risk for PDAC at Oregon Health and&#xD;
        Science University, New York University and University of Nebraska Medical Center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to understand and the willingness to sign an informed consent document&#xD;
&#xD;
          -  Own a smartphone that uses Android or Apple iOS operating systems&#xD;
&#xD;
          -  Participant must have one of the following:&#xD;
&#xD;
               -  Individuals with newly-diagnosed, treatment naive PDAC - all stages (applicable&#xD;
                  to Stage 1 only), or&#xD;
&#xD;
               -  Individuals with at least one of the following family phenotype and age will be&#xD;
                  included:&#xD;
&#xD;
                    -  Two or more relatives with PDAC on the same side of the family, where 2 PDAC&#xD;
                       affected individuals are first-degree related (FDR) AND at least one&#xD;
                       PDAC-affected individual is an FDR of the subject; Age &gt;= 50 years OR 10&#xD;
                       years before onset in family&#xD;
&#xD;
                    -  Two affected FDR with PDAC; Age &gt;= 50 years OR 10 years before onset of an&#xD;
                       FDR&#xD;
&#xD;
                    -  Any of BRCA1, BRCA2, PALB2, ATM mutations confirmed pathogenic or likely&#xD;
                       pathogenic; Age &gt;= 50 years OR 10 years before onset of an FDR or&#xD;
                       second-degree relative (SDR)&#xD;
&#xD;
                    -  Familial atypical multiple mole-melanoma (FAMMM) with confirmed pathogenic&#xD;
                       or likely pathogenic mutation variants in: p16, CDKN2A; Age &gt;= 50 years&#xD;
&#xD;
                    -  Known mutation carrier for STK11 (Peutz-Jeghers syndrome); Age &gt;= 50 years&#xD;
&#xD;
                    -  Lynch syndrome (hereditary nonpolyposis colorectal cancer [HNPCC]) with&#xD;
                       confirmed pathogenic or likely pathogenic variants in: MLH1, MSH2, MSH6,&#xD;
                       PMS2, or EPCAM; Age &gt;= 50 years OR 10 years before onset of an FDR or SDR&#xD;
&#xD;
                    -  Hereditary pancreatitis with confirmed PRSS1 pathogenic or likely pathogenic&#xD;
                       history of pancreatitis; Age &gt;= 50 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any medical conditions that in the opinion of the investigators would compromise&#xD;
             participant safety and/or the integrity of the data&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aaron Grossberg</last_name>
    <role>Principal Investigator</role>
    <affiliation>OHSU Knight Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198-7680</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laura and Isaac Perlmutter Cancer Center at NYU Langone</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OHSU Knight Cancer Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>November 17, 2022</last_update_submitted>
  <last_update_submitted_qc>November 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>OHSU Knight Cancer Institute</investigator_affiliation>
    <investigator_full_name>Aaron Grossberg</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT04400903
org study id: STUDY00021185
secondary id: NCI-2020-03178
secondary id: STUDY00021185
secondary id: R01CA264133
nct id: NCT04400903
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study examines heart rate monitoring variability for the early detection of pancreatic
      cancer. Pancreatic cancer is a very difficult disease to detect early. This study is being
      done to observe the heart rate variability in patients with pancreatic cancer compared to
      undiagnosed individuals with increased risk of developing pancreatic cancer. This may help
      researchers determine if pancreatic occurrences/recurrences (chance of coming back) can be
      detected sooner through monitoring heart rate and activity.
PRIMARY OBJECTIVES:

      I. To determine whether heart rate variability (HRV) is reduced in patients with pancreatic
      ductal adenocarcinoma (PDAC) compared with individuals at increased risk of developing PDAC.
      (Stage I) II. To assess the feasibility of long-term compliance using a wearable device.
      (Stage II)

      SECONDARY OBJECTIVES:

      I. To assess compliance with using a wearable device. (Stage I and II) II. To validate
      effectiveness of virtual device training. (Stage I and II) III. To determine whether HRV is
      reduced in participants at high-risk of developing PDAC. (Stage II) IV. To characterize
      timing and occurrence of PDAC among high-risk without disease. (Stage II) V. To characterize
      timing and occurrence of PDAC among participants at high-risk of developing PDAC. (Stage II)

      EXPLORATORY OBJECTIVES:

      I. To investigate the relationship between changes in HRV relative to sarcopenia-related body
      composition characteristics in PDAC patients. (Stage I) II. To investigate the relationship
      between the pNN50 HRV measure and PDAC diagnosis. (Stage I and II) III. To compare changes in
      sleep biometrics among all participants. (Stage I and II) IV. To evaluate changes in
      health-related quality of life assessments among all participants. (Stage I and II) V. To
      evaluate participant satisfaction with virtual device instruction.

      OUTLINE:

      Participants undergo HRV monitoring using an activity monitor (WHOOP) for a minimum of 5 days
      weekly for up to 1 year in patients with newly-diagnosed PDAC and up to 5 years for patients
      in high risk group.
observational model: Case-Control
time perspective: Prospective
measure: Magnitude of heart rate variability (HRV) decline (Stage I)
time frame: Up to 1 year after enrollment
description: As measured by root mean square of the successive differences (RMSSD) in pancreatic ductal adenocarcinoma (PDAC) patients and in high-risk participants.
measure: Compliance statistics for wristband use (Stage II)
time frame: Until onset of PDAC, study withdrawal, or death, whichever occurs first, assessed up to 5 years after enrollment
description: Defined as the percentage of days during which data were collected during at least 70% of the hours.
measure: Compliance statistics for wristband use for all participants (Stage I, II)
time frame: Up to 6 weeks and 6 months after enrollment and device activation
description: Defined as the percentage of days during which data were collected for at least 70% of the hours.
measure: Effectiveness of virtual training (Stage I, II)
time frame: Up to 1 week after enrollment and device activation
description: Defined as the percentage of participants for whom high quality data are available within 3 days of set up. The pattern of missing data, and the percentage of participants able to collect data will be presented graphically. Will also associate the compliance with patient characteristics, regions and seasons to understand what may impact the compliance rate.
measure: Magnitude of HRV change (Stage II)
time frame: Up to 5 years post enrollment
description: As measured by RMSSD, in participants at high-risk of developing PDAC.
measure: Incidence of PDAC among high-risk participants (Stage II)
time frame: Up to 5 years post enrollment
measure: Time of PDAC diagnosis among high-risk participants who developed PDAC (Stage II)
time frame: Up to 5 years post enrollment
arm group label: Observational (HRV monitoring, questionnaire)
description: Participants undergo HRV monitoring using an activity monitor (WHOOP) for a minimum of 5 days weekly for up to 1 year in patients with newly-diagnosed PDAC and up to 5 years for patients in high risk group.
intervention type: Device
intervention name: Activity Monitor
description: Undergo HRV monitoring via WHOOP device
arm group label: Observational (HRV monitoring, questionnaire)
other name: Activity Tracker
other name: Activity Tracker Device
other name: Physical Activity Measuring Device
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Observational (HRV monitoring, questionnaire)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Complete questionnaires
arm group label: Observational (HRV monitoring, questionnaire)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aaron Grossberg
role: Principal Investigator
affiliation: OHSU Knight Cancer Institute
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: OHSU Knight Cancer Institute
investigator full name: Aaron Grossberg
investigator title: Principal Investigator
mesh term: Pancreatic Neoplasms