Clinical trial · Observational
Monitoring Heart Rate Variability for the Early Detection of Pancreatic Cancer
A Prospective, Multi-Center Investigational Study of Heart Rate Variability Monitoring for the Early Detection of Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage IA Pancreatic Cancer AJCC v8 | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Pancreatic Cancer AJCC v8 | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Pancreatic Cancer AJCC v8 | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Activity Monitor | Device | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- 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
Primary outcomes (2)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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 dataReferences
Publications (0)
Data not yet available