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Trial Title: TRUST-ACE - Anticancer-treatment Cardiotoxicity Identification by Echocardiography

NCT ID: NCT06310330

Condition: Breast Neoplasm Malignant Primary

Conditions: Official terms:
Breast Neoplasms
Neoplasms
Cardiotoxicity

Conditions: Keywords:
echocardiography
breast cancer
artificial intelligence
cardiotoxicity

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Randomization 1:1 to two different modes of follow-up

Primary purpose: Diagnostic

Masking: None (Open Label)

Masking description: No masking

Intervention:

Intervention type: Diagnostic Test
Intervention name: Comprehensive echocardiographic follow-up
Description: Comprehensive echocardiographic follow-up for identification of CRTCD in breast cancer patients
Arm group label: Usual care

Intervention type: Diagnostic Test
Intervention name: Simplified echocardiographic follow-up
Description: Simplified echocardiographic follow-up for identification of CRTCD in breast cancer patients
Arm group label: Simplified care

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 (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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Breast cancer and referral for follow-up to identify potential CTRCD Exclusion Criteria: - Not willing or able to consent

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: St. Olavs hospital

Address:
City: Trondheim
Zip: 7491
Country: Norway

Status: Recruiting

Contact:
Last name: Rune Wiseth, MD, PhD

Phone: 92247845

Phone ext: 47
Email: rune.wiseth@stolav.no

Start date: March 8, 2024

Completion date: December 31, 2026

Lead sponsor:
Agency: Norwegian University of Science and Technology
Agency class: Other

Collaborator:
Agency: St. Olavs Hospital
Agency class: Other

Source: Norwegian University of Science and Technology

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06310330

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