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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-11335 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 21466 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| R21CA261797 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiogram Recording | Procedure | Undergo assessment via echo |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 2â„¢ 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saro H Armenian | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2022 |
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| Questionnaire Administration | Other | Ancillary Studies |
|
| Stress Cardiac Magnetic Resonance Imaging | Procedure | Undergo assessment via CMR |
|
| Wireless Synchronized Cardiac Function Monitoring Device | Device | SphygmoCor® Xcel Oscar 2™ Ambulatory Blood Pressure Monitor |
|
| Up to 2 years |
| Jul 1, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 22, 2023 | Sep 11, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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