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

University of Montreal

Status: Active, not recruiting

Conditions: Breast Cancer; Lymphoma; Leukemia

Treatments: Other: Data Collection; Diagnostic Test: Cardiac Imaging

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04541212

MHICC-2018-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 169 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

169 participants in 2 patient groups

Cohort A

Description:

Prospective

Treatment:

Diagnostic Test: Cardiac Imaging

Cohort B

Description:

Retrospective/Prospective

Treatment:

Other: Data Collection

Diagnostic Test: Cardiac Imaging