A Prospective, Multi-Center Investigational Study of Heart Rate Variability Monitoring for the Early Detection of Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- Compliance statistics for wristband use (Stage II)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Any medical conditions that in the opinion of the investigators would compromise participant safety and/or the integrity of the data
结局指标
主要结局
Compliance statistics for wristband use (Stage II)
时间窗: 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.
Magnitude of heart rate variability (HRV) decline (Stage I)
时间窗: 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.
次要结局
- Incidence of PDAC among high-risk participants (Stage II)(Up to 5 years post enrollment)
- Effectiveness of virtual training (Stage I, II)(Up to 1 week after enrollment and device activation)
- Compliance statistics for wristband use for all participants (Stage I, II)(Up to 6 weeks and 6 months after enrollment and device activation)
- Magnitude of HRV change (Stage II)(Up to 5 years post enrollment)
- Time of PDAC diagnosis among high-risk participants who developed PDAC (Stage II)(Up to 5 years post enrollment)
研究者
Aaron Grossberg
Principal Investigator
OHSU Knight Cancer Institute