Breast Cancer, Leukemia, Lymphoma
Conditions
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.
Interventions
DIAGNOSTIC_TESTCardiac Imaging
Cardiac Imaging: echography, ECG, MRI Blood tests: Lipid profile, hs-CRP, metabolic markers, HDL functionality, pharmacogenetic testing (optional), hematocrit, pregnancy test
OTHERData Collection
Collection of retrospective data
Sponsors
AstraZeneca
Montreal Heart Institute
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial extracellular volume (ECV) | Change from baseline to 3, 6, 12,and 24 months | Cohort A |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomarker of myocardial injury (high-sensitivity troponin (hs-cTn)) | Change from baseline to 3, 6, 12,and 24 months. | Cohort A |
| Biomarker of elevated LV fitting pressure (N-Terminal-pro-hormone B-type Natriuretic Peptide (NT-proBNP)) | Change from baseline to 3, 6, 12,and 24 months. | Cohort A |
| Left ventricular (LV) systolic function (global and regional) | Change from baseline to 3, 6, 12,and 24 months. | Cohort A |
| Clonal hematopoiesis associated gene mutations. | Change from baseline to 24 months.. | Cohort A |
| Telomere length measurement | Change from baseline to 24 months.. | Cohort A |
| Biomarker of inflammation (high-sensitivity C-reactive protein (hs-CRP)) | Change from baseline to 3, 6, 12,and 24 months. | Cohort A |
Countries
Canada
Outcome results
None listed