Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04541212

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CIUSSS Ouest de l'ile de Montreal - St-Mary's Hospital, Montreal, Quebec, Canada

Loading trial locations.

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac Imaging

Diagnostic Test

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

Data Collection

Other

Collection of retrospective data

Primary outcomes

  1. Myocardial extracellular volume (ECV)

    Time frame: Change from baseline to 3, 6, 12,and 24 months

    Cohort A

  2. Myocardial extracellular volume (ECV)

    Time frame: Change from baseline to prior study entry, 12 and 24 months post study entry.

    Cohort B

Secondary outcomes

  1. Left ventricular (LV) systolic function (global and regional)

    Time frame: Change from baseline to 3, 6, 12,and 24 months.

    Cohort A

  2. Biomarker of myocardial injury (high-sensitivity troponin (hs-cTn))

    Time frame: Change from baseline to 3, 6, 12,and 24 months.

    Cohort A

  3. Biomarker of elevated LV fitting pressure (N-Terminal-pro-hormone B-type Natriuretic Peptide (NT-proBNP))

    Time frame: Change from baseline to 3, 6, 12,and 24 months.

    Cohort A

  4. Biomarker of inflammation (high-sensitivity C-reactive protein (hs-CRP))

    Time frame: Change from baseline to 3, 6, 12,and 24 months.

    Cohort A

  5. Clonal hematopoiesis associated gene mutations.

    Time frame: Change from baseline to 24 months..

    Cohort A

  6. Telomere length measurement

    Time frame: Change from baseline to 24 months..

    Cohort A

  7. Left ventricular (LV) systolic function (global and regional)

    Time frame: Change from study entry to 12 and 24 months.

    Cohort B

  8. Biomarker of myocardial injury (high-sensitivity troponin (hs-cTn))

    Time frame: Change from study entry to 12 and 24 months.

    Cohort B

  9. Biomarker of elevated LV fitting pressure (N-Terminal-pro-hormone B-type Natriuretic Peptide (NT-proBNP))

    Time frame: Change from study entry to 12 and 24 months.

    Cohort B

  10. Biomarker of inflammation (high-sensitivity C-reactive protein (hs-CRP))

    Time frame: Change from study entry to 12 and 24 months.

    Cohort B

  11. Clonal hematopoiesis associated gene mutations.

    Time frame: Change from baseline to 24 months..

    Cohort B

  12. Telomere length measurement

    Time frame: Change from baseline to 24 months..

    Cohort B

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Collaborators

  • AstraZeneca

Registry information

Acronym: CarChem

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2020
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.