Hematopoietic and Lymphoid Cell NeoplasmNCT05138991
Reproducibility and Accuracy of a Portable System for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors
A study testing Echocardiogram Recording, Questionnaire Administration and Stress Cardiac Magnetic Resonance Imaging in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by City of Hope Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Echocardiogram Recording, Questionnaire Administration and Stress Cardiac Magnetic Resonance Imaging
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2022to 16 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Previously enrolled in IRB# 14154.
- Able to understand and sign the study specific informed consent form (ICF).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Assessment of the Reproducibility and Accuracy of a Portable System for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors
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.
Read the detailed description
Primary Objective(s)
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.
- Being tested
- Echocardiogram Recording, Questionnaire Administration, Stress Cardiac Magnetic Resonance Imaging, Wireless Synchronized Cardiac Function Monitoring Device
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiogram RecordingProcedure or surgery
Also called Echocardiogram
Undergo assessment via echo
Questionnaire AdministrationOther
Ancillary Studies
Stress Cardiac Magnetic Resonance ImagingProcedure or surgery
Undergo assessment via CMR
Wireless Synchronized Cardiac Function Monitoring DeviceDevice
SphygmoCor® Xcel Oscar 2™ Ambulatory Blood Pressure Monitor
| Study group | Role | What they receive |
|---|---|---|
| Screening (echo, CMR, Tonometry-based system) | Experimental | 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. Receives: Procedure: Echocardiogram Recording; Other: Questionnaire Administration; Procedure: Stress Cardiac Magnetic Resonance Imaging; Device: Wireless Synchronized Cardiac Function Monitoring Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Secondary outcomes (1)
Cost-effectiveness of tonometry-based screening in the clinic setting and at home.
Will apply the sensitivity and specificity of echo, CMR, and the Oscar 2™ ABPM system (clinic, home-based) to compare the number of asymptomatic cardiac dysfunction cases identified via each method. Screening costs for echo and CMR, including costs of clinical services, will be obtained from the 2020 Centers for Medicare \& Medicaid Services (CMS).
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start22 Jun 2022
- Primary completion16 Jul 2026 (estimated)
- Study completion16 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Saro H Armenian, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138991
- Sponsor's protocol ID
- 21466
- Other IDs
- NCI-2021-11335, 21466, P30CA033572, R21CA261797
- Status last verified
- Sep 2025
- First submitted
- 22 Nov 2021
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Reproducibility and Accuracy of a Portable System for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors
- ClinicalTrials.gov ID
- NCT05138991
- Acronym / sponsor ID
- 21466
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 149 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 16 Jul 2026 (estimated)
- Study completion
- 16 Jul 2026 (estimated)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective(s)
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (echo, CMR, Tonometry-based system) | Experimental | Procedure: Echocardiogram Recording, Other: Questionnaire Administration, Procedure: Stress Cardiac Magnetic Resonance Imaging, Device: Wireless Synchronized Cardiac Function Monitoring DevicePatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Previously enrolled in IRB# 14154.
- Able to understand and sign the study specific informed consent form (ICF).
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiogram RecordingAlso: EchocardiogramUndergo assessment via echo | Procedure or surgery | Screening (echo, CMR, Tonometry-based system) |
| Questionnaire AdministrationAncillary Studies | Other | Screening (echo, CMR, Tonometry-based system) |
| Stress Cardiac Magnetic Resonance ImagingUndergo assessment via CMR | Procedure or surgery | Screening (echo, CMR, Tonometry-based system) |
| Wireless Synchronized Cardiac Function Monitoring DeviceSphygmoCor® Xcel Oscar 2™ Ambulatory Blood Pressure Monitor | Device | Screening (echo, CMR, Tonometry-based system) |
Primary outcome
Accuracy of ejection fraction (EF) in the clinic setting, and determine its reproducibility at home.
Time frame: Up to 2 years
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.
1 secondary outcome
Cost-effectiveness of tonometry-based screening in the clinic setting and at home.
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saro H Armenian principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echocardiogram Recording, Questionnaire Administration and Stress Cardiac Magnetic Resonance Imaging in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of ejection fraction (EF) in the clinic setting, and determine its reproducibility at home. (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.