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

NCT04541212 | Active Not Recruiting

• 1 other identifier: MHICC-2018-003
• Study Type: observational
• Target: 169
• Locations: 1 country
• Sites: 6

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.

Conditions

Breast Cancer; Lymphoma; Leukemia

Outcome Measures

Primary Outcomes (2)

• Myocardial extracellular volume (ECV)

  Cohort A

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

• Myocardial extracellular volume (ECV)

  Cohort B

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

Secondary Outcomes (12)

• Left ventricular (LV) systolic function (global and regional)

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

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

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

• 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.

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

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

• Clonal hematopoiesis associated gene mutations.

  Change from baseline to 24 months..

Study Arms (2)

Cohort A

Prospective

Diagnostic Test: Cardiac Imaging

Cohort B

Retrospective/Prospective

Diagnostic Test: Cardiac Imaging; Other: Data Collection

Interventions

Cardiac Imaging DIAGNOSTIC_TEST

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

Also known as: Blood tests

Cohort A; Cohort B

Data Collection OTHER

Collection of retrospective data

Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montreal Heart Institute: lead
• AstraZeneca: collaborator

Study Sites (6)

Centre Hospitalier de l'université de Montréal (CHUM)

Montreal, Quebec, H2X0C1, Canada

Location

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

Montreal, Quebec, H3T 1M5, Canada

Location

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

Montreal, Quebec, Canada

Location

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

Montreal, Quebec, Canada

Location

Montreal Heart Institute

Montreal, Quebec, Canada

Location

CISSSS de Lanaudière_Hôpital Pierre LeGardeur (referring site)

Terrebonne, Quebec (QC), J6V 2H2, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphoma; Leukemia

Interventions

Hematologic Tests; Data Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jean-Claude Tardif, MD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: September 9, 2020
• Study Start: December 2, 2021
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)