Reproducibility and Accuracy of a Portable System for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors
Assessment of the Reproducibility and Accuracy of a Portable System for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors
4 other identifiers
interventional
149
1 country
1
Brief Summary
The clinical trial compares the reproducibility and accuracy of cardiac tonometry-based portable systems that may detect early cardiac dysfunction (SphygmoCor® Xcel and Oscar 2™ ambulatory blood pressure monitor) at home and in the clinic to currently available screening tests for heart failure including echocardiogram (echo) and cardiovascular magnetic resonance (CMR). The SphygmoCor® Xcel and Oscar 2™ systems may help detect cardiac dysfunction earlier than other available screening tests because it can be self-administered outside of the clinic. This study aims to test the accuracy and practicality of these devices in the clinic setting and at home.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2021
CompletedFirst Posted
Study publicly available on registry
December 1, 2021
CompletedStudy Start
First participant enrolled
June 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 16, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 16, 2026
September 23, 2025
September 1, 2025
4.1 years
November 22, 2021
September 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Accuracy of ejection fraction (EF) in the clinic setting, and determine its reproducibility at home.
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.
Up to 2 years
Secondary Outcomes (1)
Cost-effectiveness of tonometry-based screening in the clinic setting and at home.
Up to 2 years
Study Arms (1)
Screening (echo, CMR, Tonometry-based system)
EXPERIMENTALPatients 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.
Interventions
Undergo assessment via echo
Undergo assessment via CMR
SphygmoCor® Xcel Oscar 2™ Ambulatory Blood Pressure Monitor
Eligibility Criteria
You may qualify if:
- Previously enrolled in IRB# 14154.
- Able to understand and sign the study specific informed consent form (ICF).
You may not qualify if:
- Participants cannot be actively receiving cancer-directed therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- City of Hope Medical Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
City of Hope Medical Center
Duarte, California, 91010, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Saro H Armenian
City of Hope Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2021
First Posted
December 1, 2021
Study Start
June 22, 2022
Primary Completion (Estimated)
July 16, 2026
Study Completion (Estimated)
July 16, 2026
Last Updated
September 23, 2025
Record last verified: 2025-09