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Breast CancerCarChemNCT04541212

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

An observational study of Breast Cancer and Lymphoma, run by Montreal Heart Institute at 6 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Lymphoma, Leukemia
What is being tested?
Cardiac Imaging and Data Collection
How many people
169 participants
Where
6 sitesCanada
Study dates
2 Dec 2021to 30 Sep 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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).

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Canada6 sites

  • Centre Hospitalier de l'université de Montréal (CHUM)

    Montreal, Quebec, H2X0C1

  • CIUSSS Ouest de l'ile de Montreal - St-Mary's Hospital

    Montreal, Quebec, H3T 1M5

  • CIUSSS de l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont

    Montreal, Quebec

  • CIUSSS du Centre-Ouest de l'Île de Montréal - Jewish General Hospital

    Montreal, Quebec

  • Montreal Heart Institute

    Montreal, Quebec

  • CISSSS de Lanaudière_Hôpital Pierre LeGardeur (referring site)

    Terrebonne, Quebec (QC), J6V 2H2

Other trials in Canada

About this study

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.

Read the 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.

Being tested
Cardiac Imaging, Data Collection
Medical subject headings
Breast Neoplasms, Lymphoma, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac ImagingDiagnostic test

    Also called Blood tests

    Cardiac Imaging: echography, ECG, MRI Blood tests: Lipid profile, hs-CRP, metabolic markers, HDL functionality, pharmacogenetic testing (optional), hematocrit, pregnancy test

  • Data CollectionOther

    Collection of retrospective data

Study groups in NCT04541212
Study groupRoleWhat they receive
Cohort AProspective
Receives: Diagnostic Test: Cardiac Imaging
Cohort BRetrospective/Prospective
Receives: Diagnostic Test: Cardiac Imaging; Other: Data Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Myocardial extracellular volume (ECV)

    Cohort A

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

  2. Myocardial extracellular volume (ECV)

    Cohort B

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

Secondary outcomes (12)

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

    Cohort A

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

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

    Cohort A

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

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

    Cohort A

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

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

    Cohort A

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

  5. Clonal hematopoiesis associated gene mutations.

    Cohort A

    Measured: Change from baseline to 24 months..

  6. Telomere length measurement

    Cohort A

    Measured: Change from baseline to 24 months..

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

    Cohort B

    Measured: Change from study entry to 12 and 24 months.

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

    Cohort B

    Measured: Change from study entry to 12 and 24 months.

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

    Cohort B

    Measured: Change from study entry to 12 and 24 months.

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

    Cohort B

    Measured: Change from study entry to 12 and 24 months.

  11. Clonal hematopoiesis associated gene mutations.

    Cohort B

    Measured: Change from baseline to 24 months..

  12. Telomere length measurement

    Cohort B

    Measured: Change from baseline to 24 months..

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2020
  2. Study start2 Dec 2021
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
169 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04541212
Sponsor's protocol ID
MHICC-2018-003
Acronym
CarChem
Status last verified
Oct 2026
First submitted
30 Jul 2020
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Lymphoma, run by Montreal Heart Institute at 6 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myocardial extracellular volume (ECV) (time frame: Change from baseline to 3, 6, 12,and 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04541212.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

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