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

Recruiting

• Conditions: Sarcoma
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06511388
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2016-01-20
• Study First Submitted: 2024-06-28
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-19
• Last Update Submitted: 2024-07-19
• Study First Posted: 2024-07-22
• Last Update Posted: 2024-07-22
• Primary Completion: 2028-01-20
• Study Completion: 2028-01-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional Study	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.

Primary Outcome Measures

Name	Time	Method
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	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 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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States