Status:
TERMINATED
Monitoring Heart Rate Variability for the Early Detection of Pancreatic Cancer
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
Oregon Health and Science University
American Association for Cancer Research
Conditions:
Pancreatic Ductal Adenocarcinoma
Stage I Pancreatic Cancer AJCC v8
Eligibility:
All Genders
50-75 years
Brief Summary
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 t...
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 ...
Eligibility Criteria
Inclusion
- 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
- Any medical conditions that in the opinion of the investigators would compromise participant safety and/or the integrity of the data
Key Trial Info
Start Date :
September 21 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04400903
Start Date
September 21 2020
End Date
September 30 2022
Last Update
November 22 2022
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
2
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
3
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239