Study Stopped
Low accrual
Cardiotoxic Effects of Chemotherapy in Patients With Sarcomas: A Two and Three-dimensional Echocardiographic Speckle Tracking Imaging Study
2 other identifiers
observational
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2016
CompletedFirst Submitted
Initial submission to the registry
June 28, 2024
CompletedFirst Posted
Study publicly available on registry
July 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 9, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 9, 2024
CompletedOctober 10, 2025
October 1, 2025
8.7 years
June 28, 2024
October 8, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (1)
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.
Interventions
Eligibility Criteria
Patients with diagnosis of sarcoma undergoing chemotherapy treatment
You may qualify if:
- Patients followed at Mayo Clinic and treated for sarcoma with doxorubicin as first-line treatment
You may not qualify if:
- First-line treatment not including doxorubicin
- Treatment performed outside of Mayo Clinic with different protocols
- Age \< 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hector R. Villarraga, M.D.
Mayo Clinic in Rochester
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2024
First Posted
July 22, 2024
Study Start
January 20, 2016
Primary Completion
October 9, 2024
Study Completion
October 9, 2024
Last Updated
October 10, 2025
Record last verified: 2025-10