- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04400903
Monitoring Heart Rate Variability for the Early Detection of Pancreatic Cancer
A Prospective, Multi-Center Investigational Study of Heart Rate Variability Monitoring for the Early Detection of Pancreatic Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Nebraska
-
Omaha, Nebraska, United States, 68198-7680
- University of Nebraska Medical Center
-
-
New York
-
New York, New York, United States, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
-
-
Oregon
-
Portland, Oregon, United States, 97239
- OHSU Knight Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- Any medical conditions that in the opinion of the investigators would compromise participant safety and/or the integrity of the data
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Ancillary studies
Other Names:
Complete questionnaires
Undergo HRV monitoring via WHOOP device
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Magnitude of heart rate variability (HRV) decline (Stage I)
Time Frame: Up to 1 year after enrollment
|
As measured by root mean square of the successive differences (RMSSD) in pancreatic ductal adenocarcinoma (PDAC) patients and in high-risk participants.
|
Up to 1 year after enrollment
|
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
|
Defined as the percentage of days during which data were collected during at least 70% of the hours.
|
Until onset of PDAC, study withdrawal, or death, whichever occurs first, assessed up to 5 years after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Defined as the percentage of days during which data were collected for at least 70% of the hours.
|
Up to 6 weeks and 6 months after enrollment and device activation
|
Effectiveness of virtual training (Stage I, II)
Time Frame: Up to 1 week after enrollment and device activation
|
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.
|
Up to 1 week after enrollment and device activation
|
Magnitude of HRV change (Stage II)
Time Frame: Up to 5 years post enrollment
|
As measured by RMSSD, in participants at high-risk of developing PDAC.
|
Up to 5 years post enrollment
|
Incidence of PDAC among high-risk participants (Stage II)
Time Frame: Up to 5 years post enrollment
|
Up to 5 years post enrollment
|
|
Time of PDAC diagnosis among high-risk participants who developed PDAC (Stage II)
Time Frame: Up to 5 years post enrollment
|
Up to 5 years post enrollment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Aaron Grossberg, OHSU Knight Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00021185 (Other Identifier: OHSU Knight Cancer Institute)
- NCI-2020-03178 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- R01CA264133 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pancreatic Ductal Adenocarcinoma
-
Roswell Park Cancer InstituteNot yet recruitingStage II Pancreatic Cancer AJCC v8 | Stage III Pancreatic Cancer AJCC v8 | Stage IV Pancreatic Cancer AJCC v8 | Metastatic Pancreatic Ductal Adenocarcinoma | Locally Advanced Pancreatic Ductal Adenocarcinoma | Advanced Pancreatic Ductal Adenocarcinoma | Unresectable Pancreatic Ductal Adenocarcinoma and other conditionsUnited States
-
Georgetown UniversityERYtech PharmaActive, not recruitingMetastatic Pancreatic Ductal Adenocarcinoma | Locally Advanced Pancreatic Ductal AdenocarcinomaUnited States
-
Gilead SciencesTerminatedPreviously Untreated Pancreatic Ductal Adenocarcinoma | Relapsed/Refractory Pancreatic Ductal AdenocarcinomaUnited States
-
SOFIERecruitingFAP | PDAC - Pancreatic Ductal AdenocarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingBorderline Resectable Pancreatic Adenocarcinoma | Resectable Pancreatic Ductal Adenocarcinoma | Locally Advanced Pancreatic Ductal AdenocarcinomaUnited States
-
Memorial Sloan Kettering Cancer CenterRecruitingPancreatic Cancer | Pancreatic Ductal Adenocarcinoma | Metastatic Pancreatic Cancer | Metastatic Pancreatic Ductal Adenocarcinoma | Primary Pancreatic Ductal AdenocarcinomaUnited States
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Bristol-Myers SquibbRecruitingPancreatic Ductal Adenocarcinoma | Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)United States
-
UMC UtrechtDutch Pancreatic Cancer Group (DPCG)Enrolling by invitationResectable Pancreatic Ductal Adenocarcinoma | Recurrent Pancreatic Ductal AdenocarcinomaNetherlands
-
OHSU Knight Cancer InstituteGenentech, Inc.; Oregon Health and Science University; American Association for... and other collaboratorsRecruitingStage II Pancreatic Cancer AJCC v8 | Stage III Pancreatic Cancer AJCC v8 | Stage IV Pancreatic Cancer AJCC v8 | Metastatic Pancreatic Ductal Adenocarcinoma | Locally Advanced Pancreatic Ductal Adenocarcinoma | Unresectable Pancreatic Ductal AdenocarcinomaUnited States
-
Sohag UniversityCompletedPancreatic Adenocarcinoma
Clinical Trials on Quality-of-Life Assessment
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol Specific | Malignant NeoplasmUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)RecruitingChildhood Malignant NeoplasmUnited States, Canada, Puerto Rico, Australia, New Zealand
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
-
Wake Forest University Health SciencesWithdrawnLung Metastases | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Recurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma
-
City of Hope Medical CenterNational Cancer Institute (NCI)Recruiting
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | COVID-19 InfectionUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | COVID-19 InfectionUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | Neuropathy | COVID-19 InfectionUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingCervical Carcinoma | Endometrial Carcinoma | Vaginal Carcinoma | Malignant Female Reproductive System Neoplasm | Vulvar CarcinomaUnited States
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Active, not recruitingMetastatic Colorectal Carcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 and other conditionsUnited States