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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lymphoma; Leukemia; Breast Cancer
• Intervention / Treatment: Diagnostic test: Cardiac Imaging; Other: Data Collection

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 Type: Observational
• Enrollment (Actual): 169

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2X0C1
      • Centre Hospitalier de l'Université de Montréal (CHUM)
    • Montréal, Quebec, Canada
      • Montreal Heart Institute
    • Montréal, Quebec, Canada, H3T 1M5
      • CIUSSS Ouest de l'ile de Montreal - St-Mary's Hospital
    • Montréal, Quebec, Canada
      • CIUSSS de l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont
    • Montréal, Quebec, Canada
      • CIUSSS du Centre-Ouest de l'Île de Montréal - Jewish General Hospital
  • Quebec (QC)
    • Terrebonne, Quebec (QC), Canada, J6V 2H2
      • CISSSS de Lanaudière_Hôpital Pierre LeGardeur (referring site)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

225 patients enrolled from oncology clinics. Patients will be screened and identified at the oncology clinics. The prospective cardiac evaluations including New York Heart Association (NYHA) functional classification, transthoracic echocardiography, CMR, standard 12-lead electrocardiogram (ECG), cardiac biomarkers, lipid profile & HDL functionality tests will be performed at the Montreal Heart Institute (MHI).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A; Prospective	Diagnostic test: Cardiac Imaging; Cardiac Imaging: echography, ECG, MRI Blood tests: Lipid profile, hs-CRP, metabolic markers, HDL functionality, pharmacogenetic testing (optional), hematocrit, pregnancy test; Other Names: Blood tests
Cohort B; Retrospective/Prospective	Diagnostic test: Cardiac Imaging; Cardiac Imaging: echography, ECG, MRI Blood tests: Lipid profile, hs-CRP, metabolic markers, HDL functionality, pharmacogenetic testing (optional), hematocrit, pregnancy test; Other Names: Blood tests; Other: Data Collection; Collection of retrospective data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial extracellular volume (ECV)	Cohort A	Change from baseline to 3, 6, 12,and 24 months
Myocardial extracellular volume (ECV)	Cohort B	Change from baseline to prior study entry, 12 and 24 months post study entry.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular (LV) systolic function (global and regional)	Cohort A	Change from baseline to 3, 6, 12,and 24 months.
Biomarker of myocardial injury (high-sensitivity troponin (hs-cTn))	Cohort A	Change from baseline to 3, 6, 12,and 24 months.
Biomarker of elevated LV fitting pressure (N-Terminal-pro-hormone B-type Natriuretic Peptide (NT-proBNP))	Cohort A	Change from baseline to 3, 6, 12,and 24 months.
Biomarker of inflammation (high-sensitivity C-reactive protein (hs-CRP))	Cohort A	Change from baseline to 3, 6, 12,and 24 months.
Clonal hematopoiesis associated gene mutations.	Cohort A	Change from baseline to 24 months..
Telomere length measurement	Cohort A	Change from baseline to 24 months..
Left ventricular (LV) systolic function (global and regional)	Cohort B	Change from study entry to 12 and 24 months.
Biomarker of myocardial injury (high-sensitivity troponin (hs-cTn))	Cohort B	Change from study entry to 12 and 24 months.
Biomarker of elevated LV fitting pressure (N-Terminal-pro-hormone B-type Natriuretic Peptide (NT-proBNP))	Cohort B	Change from study entry to 12 and 24 months.
Biomarker of inflammation (high-sensitivity C-reactive protein (hs-CRP))	Cohort B	Change from study entry to 12 and 24 months.
Clonal hematopoiesis associated gene mutations.	Cohort B	Change from baseline to 24 months..
Telomere length measurement	Cohort B	Change from baseline to 24 months..

Collaborators and Investigators

• Sponsor: Montreal Heart Institute
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Jean-Claude Tardif, MD, Montreal Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2021
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Neoplasms by Site; Neoplasms; Heart Diseases; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Chemically-Induced Disorders; Skin Diseases; Breast Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Leukemia; Breast Neoplasms; Lymphoma; Cardiotoxicity
• Other Study ID Numbers: MHICC-2018-003

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