Evaluating heart risks in cancer patients receiving chemotherapy
Identification and Evaluation of Patients at Risk of Developing Cardiotoxicity After Receiving Chemotherapy for Breast Cancer, Lymphoma or Leukemia
Montreal Heart Institute · NCT04541212
This study is trying to see if chemotherapy for breast cancer, lymphoma, or leukemia can harm the heart and looks for signs that might show this risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 225 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Montreal Heart Institute (other) |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Terrebonne, Quebec (QC) and 5 other locations) |
| Trial ID | NCT04541212 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify and evaluate the occurrence of cardiac toxicity in patients diagnosed with breast cancer, lymphoma, or leukemia who are receiving anthracycline-based chemotherapy. It includes both prospective evaluations of patients scheduled for treatment and retrospective assessments of those who have received treatment within the last five years. The study will also investigate potential biomarkers of cardiotoxicity, including inflammatory response proteins and clonal hematopoiesis, through cardiac imaging and data collection. Safety will be monitored by reporting serious adverse events related to the study procedures.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with breast cancer, lymphoma, or leukemia who are scheduled to receive or have recently received anthracycline chemotherapy.
Not a fit: Patients with known cardiomyopathy, heart failure, or significant cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and prevention of heart-related complications in cancer patients undergoing chemotherapy.
How similar studies have performed: Other studies have shown success in identifying cardiotoxicity in similar patient populations, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Terrebonne, Quebec (QC) and 5 other locations
- CISSSS de Lanaudière_Hôpital Pierre LeGardeur (referring site) — Terrebonne, Quebec (QC), Canada (ENROLLING_BY_INVITATION)
- Centre Hospitalier de l'université de Montréal (CHUM) — Montreal, Quebec, Canada (RECRUITING)
- CIUSSS Ouest de l'ile de Montreal - St-Mary's Hospital — Montréal, Quebec, Canada (RECRUITING)
- CIUSSS de l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont — Montréal, Quebec, Canada (RECRUITING)
- CIUSSS du Centre-Ouest de l'Île de Montréal - Jewish General Hospital — Montréal, Quebec, Canada (RECRUITING)
- Montreal Heart Institute — Montréal, Quebec, Canada (RECRUITING)
Study contacts
- Principal investigator: Jean-Claude Tardif, MD — Montreal Heart Institute
- Study coordinator: Jean-Claude Tardif, MD
- Email: jean-claude.tardif@icm-mhi.org
- Phone: 514-376-3330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Lymphoma, Leukemia