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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-05323 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 15-002714 | Other Identifier | Mayo Clinic in Rochester |
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Low accrual
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This study is being done to identify markers that will allow researchers to identify in advance patients with sarcomas who are at highest risk for developing heart failure related to chemotherapy.
PRIMARY OBJECTIVES:
I. To detect acute and subacute changes in myocardial function by two-dimensional (2D)-Speckle Tracking Echocardiography (STE) derived strain and strain rate in sarcoma patients undergoing chemotherapeutic treatment.
Ia. To compare 2D-STE and three-dimensional (3D)-STE derived strain and strain-rate; Ib. To compare 2D-STE and 2D- and 3D-left ventricle ejection fraction (LVEF); Ic. If feasible, to compare 2D-STE and cardiac biomarkers [serum cardiac troponin T and N-terminal fragment of brain natriuretic peptide (NT-proBNP)].
II. To predict chemotherapy-induced cardiotoxicity by using 2D-STE and/or other significant parameters for early detection of cardiac dysfunction.
OUTLINE: This is an observational study.
Patients receive anthracycline once a day or split between 2-3 days per standard of care (SOC). Patients undergo 2D-STE throughout the study and have their medical records reviewed on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Patients receive anthracycline once a day or split between 2-3 days per SOC. Patients undergo 2D-STE throughout the study and have their medical records reviewed on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in myocardial function - 2D-STE | Changes in myocardial function will be assessed using 2D-STE derived strain rate. Changes will be compared to baseline over time. | Baseline, 3 months, 6 months, 1 year |
| Changes in myocardial function - 2D-STE vs 3D-STE | Differences between two-dimensional speckle tracking echocardiography (2D-STE) and three-dimensional speckle tracking echocardiography (3D-STE) derived strain will be compared at baseline and over time. | Baseline, 3 months, 6 months, 1 year |
| Changes in myocardial function - 2D-STE vs 2D-LVEF and 3D-LVEF | Differences between 2D-STE and 2D- and 3D- left ventricle ejection fraction (2D-LVEF and 3D-LVEF, respectively) will be compared at baseline and over time. | Baseline, 3 months, 6 months, 1 year |
| Changes in myocardial function - 2D-STE vs cardiac biomarkers | If feasible, 2D-STE and cardiac biomarkers [serum cardiac troponin T and N-terminal fragment of brain natriuretic peptide (NT-proBNP)] will be compared at baseline and over time. | Baseline, 3 months, 6 months, 1 year |
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Inclusion Criteria:
Exclusion Criteria:
First-line treatment not including doxorubicin
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Patients with diagnosis of sarcoma undergoing chemotherapy treatment
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| Name | Affiliation | Role |
|---|---|---|
| Hector R. Villarraga, M.D. | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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