NCT04541212

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 169 (actual)
• Sponsor: Montreal Heart Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Breast Cancer
• Lymphoma
• Leukemia

Interventions

Type	Name	Description
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	Data Collection	Collection of retrospective data

Timeline

• Start date: 2021-12-02
• Primary completion: 2027-04-30
• Completion: 2027-09-30
• First posted: 2020-09-09
• Last updated: 2025-06-15

Locations

6 sites across 1 country: Canada