Pancreatic Ductal Adenocarcinoma Clinical Trial
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.
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. ;
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