SarcomaNCT06511388
Cardiotoxic Effects of Chemotherapy in Patients With Sarcomas: A Two and Three-dimensional Echocardiographic Speckle Tracking Imaging Study
An observational study of Sarcoma, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- Non-Interventional Study
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2016to 9 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosis of sarcoma undergoing chemotherapy treatment
Who may be able to join
- Patients followed at Mayo Clinic and treated for sarcoma with doxorubicin as first-line treatment
Who cannot join
- First-line treatment not including doxorubicin
- Treatment performed outside of Mayo Clinic with different protocols
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Sarcoma
- Being tested
- Non-Interventional Study
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start20 Jan 2016
- Primary completion9 Oct 2024
- Study completion9 Oct 2024
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hector R. Villarraga, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511388
- Sponsor's protocol ID
- 15-002714
- Other IDs
- NCI-2024-05323, 15-002714
- Status last verified
- Oct 2025
- First submitted
- 28 Jun 2024
- Last updated
- 10 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiotoxic Effects of Chemotherapy in Patients With Sarcomas: A Two and Three-Dimensional Echocardiographic Speckle Tracking Imaging Study
- ClinicalTrials.gov ID
- NCT06511388
- Acronym / sponsor ID
- 15-002714
- Conditions
- Sarcoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Jan 2016 (actual)
- Primary completion
- 9 Oct 2024 (actual)
- Study completion
- 9 Oct 2024 (actual)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of sarcoma undergoing chemotherapy treatment
Key inclusion criteria (1 listed)
- Patients followed at Mayo Clinic and treated for sarcoma with doxorubicin as first-line treatment
Key exclusion criteria (3 listed)
- First-line treatment not including doxorubicin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational |
Primary outcome
Changes in myocardial function - 2D-STE
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hector R. Villarraga, M.D. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in myocardial function - 2D-STE (time frame: Baseline, 3 months, 6 months, 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.