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Pancreatic Ductal AdenocarcinomaNCT04400903

Monitoring Heart Rate Variability for the Early Detection of Pancreatic Cancer

An observational study of Pancreatic Ductal Adenocarcinoma and Stage I Pancreatic Cancer AJCC v8, run by OHSU Knight Cancer Institute at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 50 to 75 yearsHealthy volunteers can take part
What is being tested?
Activity Monitor, Quality-of-Life Assessment and Questionnaire Administration
Type of treatment
Medical device
How many people
110 participants
Where
3 sitesUnited States
Study dates
21 Sep 2020to 30 Sep 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients diagnosed with PDAC and participants at high risk for PDAC at Oregon Health and Science University, New York University and University of Nebraska Medical Center

Who may be able to join

  • Ability to understand and the willingness to sign an informed consent document
  • Own a smartphone that uses Android or Apple iOS operating systems
  • Participant must have one of the following:
  • Individuals with newly-diagnosed, treatment naive PDAC - all stages (applicable to Stage 1 only), or
  • Individuals with at least one of the following family phenotype and age will be included:
  • Two or more relatives with PDAC on the same side of the family, where 2 PDAC affected individuals are first-degree related (FDR) AND at least one PDAC-affected individual is an FDR of the subject; Age >= 50 years OR 10 years before onset in family
Show all 12Show fewer
  • Two affected FDR with PDAC; Age >= 50 years OR 10 years before onset of an FDR
  • Any of BRCA1, BRCA2, PALB2, ATM mutations confirmed pathogenic or likely pathogenic; Age >= 50 years OR 10 years before onset of an FDR or second-degree relative (SDR)
  • Familial atypical multiple mole-melanoma (FAMMM) with confirmed pathogenic or likely pathogenic mutation variants in: p16, CDKN2A; Age >= 50 years
  • Known mutation carrier for STK11 (Peutz-Jeghers syndrome); Age >= 50 years
  • Lynch syndrome (hereditary nonpolyposis colorectal cancer [HNPCC]) with confirmed pathogenic or likely pathogenic variants in: MLH1, MSH2, MSH6, PMS2, or EPCAM; Age >= 50 years OR 10 years before onset of an FDR or SDR
  • Hereditary pancreatitis with confirmed PRSS1 pathogenic or likely pathogenic history of pancreatitis; Age >= 50 years

Who cannot join

  • Any medical conditions that in the opinion of the investigators would compromise participant safety and/or the integrity of the data

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-7680

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: A Prospective, Multi-Center Investigational Study of Heart Rate Variability Monitoring for the Early Detection of Pancreatic Cancer

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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:

  1. 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.

Being tested
Activity Monitor, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Activity MonitorDevice

    Also called Activity Tracker, Activity Tracker Device, Physical Activity Measuring Device

    Undergo HRV monitoring via WHOOP device

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Complete questionnaires

Study groups in NCT04400903
Study groupRoleWhat they receive
Observational (HRV monitoring, questionnaire)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.
Receives: Device: Activity Monitor; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Magnitude of heart rate variability (HRV) decline (Stage I)

    As measured by root mean square of the successive differences (RMSSD) in pancreatic ductal adenocarcinoma (PDAC) patients and in high-risk participants.

    Measured: Up to 1 year after enrollment

  2. Compliance statistics for wristband use (Stage II)

    Defined as the percentage of days during which data were collected during at least 70% of the hours.

    Measured: Until onset of PDAC, study withdrawal, or death, whichever occurs first, assessed up to 5 years after enrollment

Secondary outcomes (5)

  1. Compliance statistics for wristband use for all participants (Stage I, II)

    Defined as the percentage of days during which data were collected for at least 70% of the hours.

    Measured: Up to 6 weeks and 6 months after enrollment and device activation

  2. Effectiveness of virtual training (Stage I, II)

    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.

    Measured: Up to 1 week after enrollment and device activation

  3. Magnitude of HRV change (Stage II)

    As measured by RMSSD, in participants at high-risk of developing PDAC.

    Measured: Up to 5 years post enrollment

  4. Incidence of PDAC among high-risk participants (Stage II)

    Measured: Up to 5 years post enrollment

  5. Time of PDAC diagnosis among high-risk participants who developed PDAC (Stage II)

    Measured: Up to 5 years post enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2020
  2. Study start21 Sep 2020
  3. Primary completion30 Sep 2022
  4. Study completion30 Sep 2022

Why it stopped: Slow accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04400903
Sponsor's protocol ID
STUDY00021185
Other IDs
NCI-2020-03178, STUDY00021185, R01CA264133
Status last verified
Nov 2022
First submitted
20 May 2020
Last updated
22 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatic Ductal Adenocarcinoma and Stage I Pancreatic Cancer AJCC v8, run by OHSU Knight Cancer Institute at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Slow accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Magnitude of heart rate variability (HRV) decline (Stage I) (time frame: Up to 1 year after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04400903.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.

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