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

Breast Cancer Clinical Trial

— CarChem  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04541212
• Other study ID #: MHICC-2018-003
• Status: Recruiting
• Start date: December 2, 2021
• Est. completion date: April 30, 2027

Study information

• Verified date: June 2024
• Source: Montreal Heart Institute
• Contact: Jean-Claude Tardif, MD
• Phone: 514-376-3330
• Email: jean-claude.tardif[@]icm-mhi.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 30, 2027
• Est. primary completion date: April 30, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cardiotoxicity
• Leukemia
• Lymphoma

Intervention

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

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'université de Montréal (CHUM)	Montreal	Quebec
Canada	CIUSSS de l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont	Montréal	Quebec
Canada	CIUSSS du Centre-Ouest de l'Île de Montréal - Jewish General Hospital	Montréal	Quebec
Canada	CIUSSS Ouest de l'ile de Montreal - St-Mary's Hospital	Montréal	Quebec
Canada	Montreal Heart Institute	Montréal	Quebec
Canada	CISSSS de Lanaudière_Hôpital Pierre LeGardeur (referring site)	Terrebonne	Quebec (QC)

Sponsors (2)

Lead Sponsor	Collaborator
Montreal Heart Institute	AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial extracellular volume (ECV)	Cohort A	Change from baseline to 3, 6, 12,and 24 months
Primary	Myocardial extracellular volume (ECV)	Cohort B	Change from baseline to prior study entry, 12 and 24 months post study entry.
Secondary	Left ventricular (LV) systolic function (global and regional)	Cohort A	Change from baseline to 3, 6, 12,and 24 months.
Secondary	Biomarker of myocardial injury (high-sensitivity troponin (hs-cTn))	Cohort A	Change from baseline to 3, 6, 12,and 24 months.
Secondary	Biomarker of elevated LV fitting pressure (N-Terminal-pro-hormone B-type Natriuretic Peptide (NT-proBNP))	Cohort A	Change from baseline to 3, 6, 12,and 24 months.
Secondary	Biomarker of inflammation (high-sensitivity C-reactive protein (hs-CRP))	Cohort A	Change from baseline to 3, 6, 12,and 24 months.
Secondary	Clonal hematopoiesis associated gene mutations.	Cohort A	Change from baseline to 24 months..
Secondary	Telomere length measurement	Cohort A	Change from baseline to 24 months..
Secondary	Left ventricular (LV) systolic function (global and regional)	Cohort B	Change from study entry to 12 and 24 months.
Secondary	Biomarker of myocardial injury (high-sensitivity troponin (hs-cTn))	Cohort B	Change from study entry to 12 and 24 months.
Secondary	Biomarker of elevated LV fitting pressure (N-Terminal-pro-hormone B-type Natriuretic Peptide (NT-proBNP))	Cohort B	Change from study entry to 12 and 24 months.
Secondary	Biomarker of inflammation (high-sensitivity C-reactive protein (hs-CRP))	Cohort B	Change from study entry to 12 and 24 months.
Secondary	Clonal hematopoiesis associated gene mutations.	Cohort B	Change from baseline to 24 months..
Secondary	Telomere length measurement	Cohort B	Change from baseline to 24 months..