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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04541212
Recruitment Status : Recruiting
First Posted : September 9, 2020
Last Update Posted : February 3, 2022
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Montreal Heart Institute

Study Description
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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.


Condition or disease Intervention/treatment
Breast Cancer Lymphoma Leukemia 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 Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Identification and Evaluation of Patients at Risk of Developing Cardiotoxicity After Receiving Chemotherapy for Breast Cancer, Lymphoma or Leukemia
Actual Study Start Date : December 2, 2021
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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 Name: 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 Name: Blood tests

Other: Data Collection
Collection of retrospective data


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
300 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).
Criteria

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 reaction to any contrast media, allergic disorders or bronchial asthma patients with history of seizure
    • Renal insufficiency (eGFR of < 45ml/min/1.73m2 using the MDRD equation)
    • Pregnant or breastfeeding women
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04541212


Contacts
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Contact: Jean-Claude Tardif, MD 514-376-3330 ext 3612 jean-claude.tardif@icm-mhi.org
Contact: Isabelle Cloutier, PhD 514-461-1300 ext 3581 isabelle.cloutier@mhicc.org

Locations
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Canada, Quebec
CIUSSS de l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont Recruiting
Montréal, Quebec, Canada
Contact: Celine Nkoue    514-252-3400 ext 6209    celine.nkoue.cemtl@ssss.gouv.qc.ca   
Principal Investigator: Luigina Mollica, MD         
Montreal Heart Institute Recruiting
Montréal, Quebec, Canada
Contact: Chantal Lacoste    514 376-3330 ext 3604    chantal.lacoste@icm-mhi.org   
Principal Investigator: Jean-Claude Tardif, M.D         
Sponsors and Collaborators
Montreal Heart Institute
AstraZeneca
Investigators
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Principal Investigator: Jean-Claude Tardif, MD Montreal Heart Institute
More Information
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Responsible Party: Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT04541212    
Other Study ID Numbers: MHICC-2018-003
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: February 3, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Breast Neoplasms
Leukemia
Cardiotoxicity
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Neoplasms by Site
Breast Diseases
Skin Diseases
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries