TRUST-ACE - Anticancer-treatment Cardiotoxicity Identification by Echocardiography

NCT06310330 | Recruiting DMC

• 1 other identifier: 2019/1059
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Neoplasm Malignant Primary

Keywords

echocardiography; breast cancer; artificial intelligence; cardiotoxicity

Outcome Measures

Primary Outcomes (1)

• Proportion of patients correctly classified with cancer therapy related cardiac dysfunction (CTRCD)

  Cancer treatment related cardiac dysfunction

  15 months

Other Outcomes (11)

• Proportion of patients misclassified as having/not having cancer therapy related cardiac dysfunction (CTRCD)

  15 months

• Risk classification

  0 days

• Risk classification

  15 months

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Standard of care echocardiographic follow-up

Diagnostic Test: Comprehensive echocardiographic follow-up

Simplified care

EXPERIMENTAL

Simplified echocardiographic follow-up

Diagnostic Test: Simplified echocardiographic follow-up

Interventions

Comprehensive echocardiographic follow-up DIAGNOSTIC_TEST

Comprehensive echocardiographic follow-up for identification of CRTCD in breast cancer patients

Usual care

Simplified echocardiographic follow-up DIAGNOSTIC_TEST

Simplified echocardiographic follow-up for identification of CRTCD in breast cancer patients

Simplified care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Not willing or able to consent

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

St. Olavs hospital

Trondheim, 7491, Norway

RECRUITING

Related Publications (1)

• 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.

  PMID: 40747448 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Cardiotoxicity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Espen Holte, MD, PhD

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Espen Holte, MD. PhD

CONTACT

92243119; espen.holte@stolav.no

Havard Dalen, MD, PhD

CONTACT

95871716; havard.dalen@ntnu.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization 1:1 to two different modes of follow-up

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 15, 2024
• Study Start: March 8, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)