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
Verified date | November 2022 |
Source | OHSU Knight Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 110 |
Est. completion date | September 30, 2022 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | OHSU Knight Cancer Institute | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
OHSU Knight Cancer Institute | American Association for Cancer Research, National Cancer Institute (NCI), Oregon Health and Science University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Up to 1 year after enrollment | |
Primary | 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. | Until onset of PDAC, study withdrawal, or death, whichever occurs first, assessed up to 5 years after enrollment | |
Secondary | 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. | Up to 6 weeks and 6 months after enrollment and device activation | |
Secondary | 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. | Up to 1 week after enrollment and device activation | |
Secondary | Magnitude of HRV change (Stage II) | As measured by RMSSD, in participants at high-risk of developing PDAC. | Up to 5 years post enrollment | |
Secondary | Incidence of PDAC among high-risk participants (Stage II) | Up to 5 years post enrollment | ||
Secondary | Time of PDAC diagnosis among high-risk participants who developed PDAC (Stage II) | Up to 5 years post enrollment |
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