Reproducibility and Accuracy of a Portable System for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors
NCT ID: NCT05138991
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
149 participants
INTERVENTIONAL
2022-06-22
2026-07-16
Brief Summary
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Detailed Description
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Validate the accuracy of ejection fraction, as measured using a tonometry-based system (SphygmoCor® Xcel), in the clinic setting, and determine the reproducibility (Oscar 2™) at home.
Secondary Objective(s)
Determine the cost-effectiveness of tonometry-based screening in the clinic setting and at home.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Screening (echo, CMR, Tonometry-based system)
Patients undergo a one time assessment of cardiac function by echo, CMR, and the Tonometry-based system system in the clinic over 4-6 hours, and will be asked to perform their home-based measurements within 1-5 days of the clinical assessment, allowing us to directly compare measurements obtained by survivors to those by research personnel. Patients also complete questionnaires at baseline.
Echocardiogram Recording
Undergo assessment via echo
Questionnaire Administration
Ancillary Studies
Stress Cardiac Magnetic Resonance Imaging
Undergo assessment via CMR
Wireless Synchronized Cardiac Function Monitoring Device
SphygmoCor® Xcel Oscar 2™ Ambulatory Blood Pressure Monitor
Interventions
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Echocardiogram Recording
Undergo assessment via echo
Questionnaire Administration
Ancillary Studies
Stress Cardiac Magnetic Resonance Imaging
Undergo assessment via CMR
Wireless Synchronized Cardiac Function Monitoring Device
SphygmoCor® Xcel Oscar 2™ Ambulatory Blood Pressure Monitor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to understand and sign the study specific informed consent form (ICF).
Exclusion Criteria
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Saro H Armenian
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2021-11335
Identifier Type: REGISTRY
Identifier Source: secondary_id
21466
Identifier Type: OTHER
Identifier Source: secondary_id
21466
Identifier Type: -
Identifier Source: org_study_id
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