TRUST-ACE - Anticancer-treatment Cardiotoxicity Identification by Echocardiography (TRUST-ACE)

March 18, 2024 updated by: Norwegian University of Science and Technology

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Norway
      • Trondheim, Norway, 7491
        • Recruiting
        • St. Olavs Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Breast cancer and referral for follow-up to identify potential CTRCD

Exclusion Criteria:

  • Not willing or able to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual care
Standard of care echocardiographic follow-up
Diagnostic test: Comprehensive echocardiographic follow-up
Comprehensive echocardiographic follow-up for identification of CRTCD in breast cancer patients
Experimental: Simplified care
Simplified echocardiographic follow-up
Diagnostic test: Simplified echocardiographic follow-up
Simplified echocardiographic follow-up for identification of CRTCD in breast cancer patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients correctly classified with cancer therapy related cardiac dysfunction (CTRCD)
Time Frame: 15 months
Cancer treatment related cardiac dysfunction
15 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk classification
Time Frame: 0 days
Risk classification for identification of CTRCD
0 days
Risk classification
Time Frame: 15 months
Risk classification for identification of CTRCD
15 months
Test-retest variability, systolic left ventricular size and function
Time Frame: 0 days
Test-retest variability of systolic left ventricular size and function
0 days
Test-retest variability, systolic left ventricular size and function
Time Frame: 15 months
Test-retest variability systolic left ventricular size and function
15 months
Test-retest variability, diastolic left ventricular size and function
Time Frame: 0 days
Test-retest variability of diastolic left ventricular function
0 days
Test-retest variability, diastolic left ventricular size and function
Time Frame: 15 months
Test-retest variability of diastolic left ventricular size and function
15 months
Test-retest variability, right ventricular size and function
Time Frame: 0 days
Test-retest variability of right ventricular size and function
0 days
Test-retest variability, right ventricular size and function
Time Frame: 15 months
Test-retest variability of right ventricular size and function
15 months
Time consumption
Time Frame: 0 days
Time used for echocardiographic examination
0 days
Time consumption
Time Frame: 15 days
Time used for echocardiographic examination
15 days
Proportion of patients misclassified as having/not having cancer therapy related cardiac dysfunction (CTRCD)
Time Frame: 15 months
Proportion of misclassified CTRCD
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

Investigators

  • Principal Investigator: Espen Holte, MD, PhD, St. Olavs Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/1059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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