Sarcoma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERNon-Interventional Study
Non-interventional study
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients followed at Mayo Clinic and treated for sarcoma with doxorubicin as first-line treatment
Exclusion criteria
* First-line treatment not including doxorubicin * Treatment performed outside of Mayo Clinic with different protocols * Age \< 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in myocardial function - 2D-STE | Baseline, 3 months, 6 months, 1 year | Changes in myocardial function will be assessed using 2D-STE derived strain rate. Changes will be compared to baseline over time. |
| Changes in myocardial function - 2D-STE vs 3D-STE | Baseline, 3 months, 6 months, 1 year | 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. |
| Changes in myocardial function - 2D-STE vs 2D-LVEF and 3D-LVEF | Baseline, 3 months, 6 months, 1 year | 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. |
| Changes in myocardial function - 2D-STE vs cardiac biomarkers | Baseline, 3 months, 6 months, 1 year | 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. |
Countries
United States
Outcome results
None listed