Cardiotoxic Effects of Chemotherapy in Patients With Sarcomas: A Two and Three-dimensional Echocardiographic Speckle Tracking Imaging Study

Cardiotoxic Effects of Chemotherapy in Patients With Sarcomas: A Two and Three-Dimensional Echocardiographic Speckle Tracking Imaging Study

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.

Study Overview

• Status: Terminated
• Conditions: Sarcoma
• Intervention / Treatment: Other: Non-Interventional Study

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis of sarcoma undergoing chemotherapy treatment

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Non-Interventional Study; Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Hector R. Villarraga, M.D., Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2016
• Primary Completion (Actual): October 9, 2024
• Study Completion (Actual): October 9, 2024

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: July 19, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Estimated): October 10, 2025
• Last Update Submitted That Met QC Criteria: October 8, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Sarcoma
• Other Study ID Numbers: 15-002714 (Other Identifier: Mayo Clinic in Rochester); NCI-2024-05323 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No