Breast Neoplasm Malignant PrimaryTRUST-ACENCT06310330
TRUST-ACE - Anticancer-treatment Cardiotoxicity Identification by Echocardiography
A study testing Comprehensive echocardiographic follow-up and Simplified echocardiographic follow-up in people with Breast Neoplasm Malignant Primary, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
TRUST-ACE will compare a simplified echocardiographic protocol focusing on ventricular function with the guideline recommended comprehensive echocardiographic examination using a randomised design in follow-up of breast-cancer patients with respect to identification of cancer treatment related cardiac dysfunction… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasm Malignant Primary
- What is being tested?
- Comprehensive echocardiographic follow-up and Simplified echocardiographic follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteNorway
- Study dates
- 8 Mar 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Breast cancer and referral for follow-up to identify potential CTRCD
Who cannot join
- Not willing or able to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
St. Olavs hospital
Trondheim, 7491
Rune Wiseth, MD, PhD, 92247845 ext. 47, rune.wiseth@stolav.no
About this study
Official title: Technology Revising Ultrasound Solutions for Tomorrow - Anticancer-treatment Cardiotoxicity Identification by Echocardiography
TRUST-ACE will compare a simplified echocardiographic protocol focusing on ventricular function with the guideline recommended comprehensive echocardiographic examination using a randomised design in follow-up of breast-cancer patients with respect to identification of cancer treatment related cardiac dysfunction (CTRCD).
Secondly, the study will evaluate whether novel tools used to improve standardization of recordings as well as automated measurements of central measurements, e.g. ejection fraction (EF) and global longitudinal strain (GLS) can improve the precision of echocardiography in daily clinical practice.
Read the detailed description
Cancer treatment related cardiac dysfunction (CTRCD) is a well-known complication to cancer treatment with implication both with respect to treatment and prognosis of the cancer as well as heart.
CTRCD, often named cardiotoxicity, usually refers to myocardial dysfunction and heart failure developing after administration of potentially cardiotoxic therapy. By precise diagnostics, adequate treatment can be started early to prevent heart failure and unnecessary discontinuation of the potential life-saving cancer treatment may be avoided. However, guideline advocated analyses of cardiac function (EF and GLS) by echocardiography are time consuming and many operators base their semi-quantitative estimates on visual assessment. Furthermore, test-retest variability for both EF and GLS are significant and may exceed the guideline recommended cut-offs for identification of cancer therapy-related cardiovascular toxicity.
The study will compare a simplified echocardiographic protocol focusing on ventricular function with the guideline recommended comprehensive echocardiographic examination using a randomized design. The study will also evaluate if novel tools for improved standardization of recordings and automated measurements of relevant measurements as ejection fraction (EF) and global longitudinal strain (GLS) can improve the diagnostic precision.
Breast cancer patients referred for follow-up at the echocardiography will be included.
Patients will be randomized 1:1 to A) examinations with two- and three-dimensional echocardiography including all central measures of cardiac size and function measured by sonographers as recommended by the European guidelines and as clinical practice or B) echocardiographic examinations focusing on the ventricles.
Subpopulations will undergo additional testing with serial echocardiographic examinations by four operators on the same day with and without use of novel tools for improved standardization of recordings and automated measurements.
- Conditions
- Breast Neoplasm Malignant Primary
- Being tested
- Comprehensive echocardiographic follow-up, Simplified echocardiographic follow-up
- Keywords
- echocardiography, breast cancer, artificial intelligence, cardiotoxicity
- Medical subject headings
- Breast Neoplasms, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive echocardiographic follow-upDiagnostic test
Comprehensive echocardiographic follow-up for identification of CRTCD in breast cancer patients
Simplified echocardiographic follow-upDiagnostic test
Simplified echocardiographic follow-up for identification of CRTCD in breast cancer patients
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Standard of care echocardiographic follow-up Receives: Diagnostic Test: Comprehensive echocardiographic follow-up |
| Simplified care | Experimental | Simplified echocardiographic follow-up Receives: Diagnostic Test: Simplified echocardiographic follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients correctly classified with cancer therapy related cardiac dysfunction (CTRCD)
Cancer treatment related cardiac dysfunction
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start8 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Neoplasm Malignant PrimaryStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization 1:1 to two different modes of follow-up
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Espen Holte, MD, PhD, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310330
- Sponsor's protocol ID
- 2019/1059
- Acronym
- TRUST-ACE
- Status last verified
- Aug 2026
- First submitted
- 7 Mar 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sabo S, Pettersen H, Boen GC, Jakobsen EO, Langoy PK, Nilsen HO, Pasdeloup D, Smistad E, Ostvik A, Lovstakken L, Stolen S, Grenne B, Dalen H, Holte E. Real-time guidance and automated measurements using deep learning to improve echocardiographic assessment of left ventricular size and function. Eur Heart J Imaging Methods Pract. 2025 Jul 21;3(2):qyaf094. doi: 10.1093/ehjimp/qyaf094. eCollection 2025 Jul.
PubMed 40747448
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Revising Ultrasound Solutions for Tomorrow - Anticancer-treatment Cardiotoxicity Identification by Echocardiography
- ClinicalTrials.gov ID
- NCT06310330
- Acronym / sponsor ID
- TRUST-ACE / 2019/1059
- Conditions
- Breast Neoplasm Malignant Primary
- Keywords
- echocardiography, breast cancer, artificial intelligence, cardiotoxicity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Mar 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.
TRUST-ACE will compare a simplified echocardiographic protocol focusing on ventricular function with the guideline recommended comprehensive echocardiographic examination using a randomised design in follow-up of breast-cancer patients with respect to identification of cancer treatment related cardiac dysfunction (CTRCD).
Secondly, the study will evaluate whether novel tools used to improve standardization of recordings as well as automated measurements of central measurements, e.g. ejection fraction (EF) and global longitudinal strain (GLS) can improve the precision of echocardiography in daily clinical practice.
Detailed description
Cancer treatment related cardiac dysfunction (CTRCD) is a well-known complication to cancer treatment with implication both with respect to treatment and prognosis of the cancer as well as heart.
CTRCD, often named cardiotoxicity, usually refers to myocardial dysfunction and heart failure developing after administration of potentially cardiotoxic therapy. By precise diagnostics, adequate treatment can be started early to prevent heart failure and unnecessary discontinuation of the potential life-saving cancer treatment may be avoided. However, guideline advocated analyses of cardiac function (EF and GLS) by echocardiography are time consuming and many operators base their semi-quantitative estimates on visual assessment. Furthermore, test-retest variability for both EF and GLS are significant and may exceed the guideline recommended cut-offs for identification of cancer therapy-related cardiovascular toxicity.
The study will compare a simplified echocardiographic protocol focusing on ventricular function with the guideline recommended comprehensive echocardiographic examination using a randomized design. The study will also evaluate if novel tools for improved standardization of recordings and automated measurements of relevant measurements as ejection fraction (EF) and global longitudinal strain (GLS) can improve the diagnostic precision.
Breast cancer patients referred for follow-up at the echocardiography will be included.
Patients will be randomized 1:1 to A) examinations with two- and three-dimensional echocardiography including all central measures of cardiac size and function measured by sonographers as recommended by the European guidelines and as clinical practice or B) echocardiographic examinations focusing on the ventricles.
Subpopulations will undergo additional testing with serial echocardiographic examinations by four operators on the same day with and without use of novel tools for improved standardization of recordings and automated measurements.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization 1:1 to two different modes of follow-up
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Diagnostic Test: Comprehensive echocardiographic follow-upStandard of care echocardiographic follow-up |
| Simplified care | Experimental | Diagnostic Test: Simplified echocardiographic follow-upSimplified echocardiographic follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Breast cancer and referral for follow-up to identify potential CTRCD
Key exclusion criteria (1 listed)
- Not willing or able to consent
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 |
|---|---|---|
| Comprehensive echocardiographic follow-upComprehensive echocardiographic follow-up for identification of CRTCD in breast cancer patients | Diagnostic test | Usual care |
| Simplified echocardiographic follow-upSimplified echocardiographic follow-up for identification of CRTCD in breast cancer patients | Diagnostic test | Simplified care |
Primary outcome
Proportion of patients correctly classified with cancer therapy related cardiac dysfunction (CTRCD)
Time frame: 15 months
Cancer treatment related cardiac dysfunction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Derived from this study: PubMed 40747448Sabo S, Pettersen H, Boen GC, Jakobsen EO, Langoy PK, Nilsen HO, Pasdeloup D, Smistad E, Ostvik A, Lovstakken L, Stolen S, Grenne B, Dalen H, Holte E. Real-time guidance and automated measurements using deep learning to improve echocardiographic assessment of left ventricular size and function. Eur Heart J Imaging Methods Pract. 2025 Jul 21;3(2):qyaf094. doi: 10.1093/ehjimp/qyaf094. eCollection 2025 Jul.
- Individual participant dataSharing planned: No
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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.
Espen Holte, MD, PhD principal investigator
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive echocardiographic follow-up and Simplified echocardiographic follow-up in people with Breast Neoplasm Malignant Primary, run by Norwegian University of Science and Technology at 1 site in Norway.
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 1 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: looking for participants now, as of the sponsor's last update on 13 Aug 2026. 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Espen Holte, MD. PhD (92243119 ext. 47, espen.holte@stolav.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients correctly classified with cancer therapy related cardiac dysfunction (CTRCD) (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06310330, which also lists 1 linked publication.
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 13 Aug 2026.