Identification and Evaluation of Patients at Risk of Developing Cardiotoxicity After Receiving Chemotherapy for Breast Cancer, Lymphoma or Leukemia

Recruiting

• Conditions: Lymphoma; Leukemia; Breast Cancer
• Interventions: Diagnostic Test: Cardiac Imaging; Other: Data Collection

• Registration Number: NCT04541212
• Lead Sponsor: Montreal Heart Institute

Brief Summary

This is an observational study of the occurrence of cardiac toxicity in patients with breast cancer,lymphoma or leukemia receiving chemotherapy including an anthracycline. Patients will be identified at the oncology clinic and will be included in the study if all eligible criteria are met. The study will involve retrospective and prospective evaluations.

Safety will be assessed through reporting of serious adverse events (SAEs) related to study procedures.

Detailed Description

The aim of this study is to identify and evaluate cardiotoxicity in patients with diagnosis of breast cancer, lymphoma or leukemia scheduled to receive anthracycline-based chemotherapy (Cohort A: prospective evaluation); and patients undergoing or having received within the last 5 years anthracycline-based chemotherapy (Cohort B: retrospective and prospective evaluations). Part A and B will be conducted in parallel. This study also has the objectif of identifying biomarkers of cardiotoxicity including inflammatory response proteins and clonal hematopoiesis.

Study Timeline

• Study First Submitted: 2020-07-30
• Study First Submitted QC: 2020-09-01
• Study First Posted: 2020-09-09
• Study Start: 2021-12-02
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-04-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

• Age 18 years or older at time of CT initiation
• Signed informed consent
• Patients with diagnosis of breast cancer,lymphoma or leukemia (including autografted subjects)
• Planned, ongoing or completed (within last 5 years) chemotherapy with anthracycline
• Left ventricular ejection fraction (LVEF) ≥50% pre-chemotherapy
• The participant is willing to undergo CMR scans and all other required study procedures

Exclusion Criteria

• Known cardiomyopathy and/or LVEF <50%

• Known heart failure

• History of myocardial infarction (MI)

• Clinically significant cardiac valvular disease

• Clinically significant pericardial effusion

• Allografted subjects

• Contraindications to CMR testing (Cohort A & prospective evaluation for Cohort B):

  • Pacemakers, other metallic implants or severe claustrophobia
  • Weight > 135 kg
  • Patients with a history of previous allergic reaction to gadolinium
  • Patients with history of seizure
  • Renal insufficiency (eGFR of < 45ml/min/1.73m2 using the MDRD equation)
  • Pregnant or breastfeeding women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort B	Data Collection	Retrospective/Prospective
Cohort A	Cardiac Imaging	Prospective
Cohort B	Cardiac Imaging	Retrospective/Prospective

Primary Outcome Measures

Name	Time	Method
Myocardial extracellular volume (ECV)	Change from baseline to prior study entry, 12 and 24 months post study entry.	Cohort B

Secondary Outcome Measures

Name	Time	Method
Left ventricular (LV) systolic function (global and regional)	Change from study entry to 12 and 24 months.	Cohort B
Biomarker of myocardial injury (high-sensitivity troponin (hs-cTn))	Change from study entry to 12 and 24 months.	Cohort B
Clonal hematopoiesis associated gene mutations.	Change from baseline to 24 months..	Cohort B
Biomarker of elevated LV fitting pressure (N-Terminal-pro-hormone B-type Natriuretic Peptide (NT-proBNP))	Change from study entry to 12 and 24 months.	Cohort B
Biomarker of inflammation (high-sensitivity C-reactive protein (hs-CRP))	Change from study entry to 12 and 24 months.	Cohort B
Telomere length measurement	Change from baseline to 24 months..	Cohort B

Trial Locations

Locations (6)

CIUSSS Ouest de l'ile de Montreal - St-Mary's Hospital; 🇨🇦 Montréal, Quebec, Canada

CIUSSS du Centre-Ouest de l'Île de Montréal - Jewish General Hospital; 🇨🇦 Montréal, Quebec, Canada

CISSSS de Lanaudière_Hôpital Pierre LeGardeur (referring site); 🇨🇦 Terrebonne, Quebec (QC), Canada

Centre Hospitalier de l'université de Montréal (CHUM); 🇨🇦 Montreal, Quebec, Canada

CIUSSS de l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont; 🇨🇦 Montréal, Quebec, Canada

Montreal Heart Institute; 🇨🇦 Montréal, Quebec, Canada