Portable system for early detection of heart issues in childhood cancer survivors
Assessment of the Reproducibility and Accuracy of a Portable System for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors
This study is testing if portable heart monitoring devices can help childhood cancer survivors catch heart problems early compared to regular tests done in a doctor's office.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT05138991 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of portable cardiac monitoring systems, specifically the SphygmoCor® Xcel and Oscar 2™, in detecting early cardiac dysfunction in childhood cancer survivors. The study compares these devices to traditional screening methods like echocardiograms and cardiovascular magnetic resonance imaging (CMR) to assess their accuracy and reproducibility in both clinical and home settings. The primary goal is to validate the accuracy of ejection fraction measurements and determine the practicality of self-administered monitoring. Additionally, the study will explore the cost-effectiveness of these screening methods.
Who should consider this trial
Good fit: Ideal candidates for this study are childhood cancer survivors who are not currently undergoing cancer treatment and can provide informed consent.
Not a fit: Patients actively receiving cancer-directed therapy or those with certain implanted medical devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enable earlier detection of cardiac dysfunction in childhood cancer survivors, leading to timely interventions and improved patient outcomes.
How similar studies have performed: While the approach of using portable monitoring systems is innovative, similar studies have shown promise in improving early detection of cardiac issues in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Previously enrolled in IRB# 14154. * Able to understand and sign the study specific informed consent form (ICF). Exclusion Criteria: * Participants cannot be actively receiving cancer-directed therapy. * Standard exclusion criteria for CMR imaging will be incorporated, and these include: implanted pacemaker or defibrillator, insulin pump, cochlear implant, central nervous system aneurismal clips, implanted neural stimulator, ocular foreign body (metal), other implanted medical devices (e.g.: drug infusion ports).
Where this trial is running
Duarte, California
- City of Hope Medical Center — Duarte, California, United States (Recruiting)
Study contacts
- Principal investigator: Saro H Armenian — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.