Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-29 @ 3:33 AM
Study NCT ID:
NCT04400903
Status:
TERMINATED
Last Update Posted:
2022-11-22
First Post:
2020-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring Heart Rate Variability for the Early Detection of Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072936', 'term': 'Fitness Trackers'}], 'ancestors': [{'id': 'D019719', 'term': 'Diagnostic Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D000076251', 'term': 'Wearable Electronic Devices'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'whyStopped': 'Slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-17', 'studyFirstSubmitDate': '2020-05-20', 'studyFirstSubmitQcDate': '2020-05-22', 'lastUpdatePostDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Magnitude of heart rate variability (HRV) decline (Stage I)', 'timeFrame': '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)', 'timeFrame': '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.'}], 'secondaryOutcomes': [{'measure': 'Compliance statistics for wristband use for all participants (Stage I, II)', 'timeFrame': '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)', 'timeFrame': '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)', 'timeFrame': '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)', 'timeFrame': 'Up to 5 years post enrollment'}, {'measure': 'Time of PDAC diagnosis among high-risk participants who developed PDAC (Stage II)', 'timeFrame': 'Up to 5 years post enrollment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Ductal Adenocarcinoma', 'Stage I Pancreatic Cancer AJCC v8', 'Stage IA Pancreatic Cancer AJCC v8', 'Stage IB Pancreatic Cancer AJCC v8']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. 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)\n\nSECONDARY OBJECTIVES:\n\nI. 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)\n\nEXPLORATORY OBJECTIVES:\n\nI. 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.\n\nOUTLINE:\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to understand and the willingness to sign an informed consent document\n* Own a smartphone that uses Android or Apple iOS operating systems\n* Participant must have one of the following:\n\n * Individuals with newly-diagnosed, treatment naive PDAC - all stages (applicable to Stage 1 only), or\n * Individuals with at least one of the following family phenotype and age will be included:\n\n * 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\n * Two affected FDR with PDAC; Age \\>= 50 years OR 10 years before onset of an FDR\n * 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)\n * Familial atypical multiple mole-melanoma (FAMMM) with confirmed pathogenic or likely pathogenic mutation variants in: p16, CDKN2A; Age \\>= 50 years\n * Known mutation carrier for STK11 (Peutz-Jeghers syndrome); Age \\>= 50 years\n * 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\n * Hereditary pancreatitis with confirmed PRSS1 pathogenic or likely pathogenic history of pancreatitis; Age \\>= 50 years\n\nExclusion Criteria:\n\n* Any medical conditions that in the opinion of the investigators would compromise participant safety and/or the integrity of the data'}, 'identificationModule': {'nctId': 'NCT04400903', 'briefTitle': 'Monitoring Heart Rate Variability for the Early Detection of Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'OHSU Knight Cancer Institute'}, 'officialTitle': 'A Prospective, Multi-Center Investigational Study of Heart Rate Variability Monitoring for the Early Detection of Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'STUDY00021185'}, 'secondaryIdInfos': [{'id': 'NCI-2020-03178', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'STUDY00021185', 'type': 'OTHER', 'domain': 'OHSU Knight Cancer Institute'}, {'id': 'R01CA264133', 'link': 'https://reporter.nih.gov/quickSearch/R01CA264133', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'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.', 'interventionNames': ['Device: Activity Monitor', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Activity Monitor', 'type': 'DEVICE', 'otherNames': ['Activity Tracker', 'Activity Tracker Device', 'Physical Activity Measuring Device'], 'description': 'Undergo HRV monitoring via WHOOP device', 'armGroupLabels': ['Observational (HRV monitoring, questionnaire)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Observational (HRV monitoring, questionnaire)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Complete questionnaires', 'armGroupLabels': ['Observational (HRV monitoring, questionnaire)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198-7680', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Laura and Isaac Perlmutter Cancer Center at NYU Langone', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'OHSU Knight Cancer Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Aaron Grossberg', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OHSU Knight Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OHSU Knight Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oregon Health and Science University', 'class': 'OTHER'}, {'name': 'American Association for Cancer Research', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Aaron Grossberg', 'investigatorAffiliation': 'OHSU Knight Cancer Institute'}}}}