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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

169 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-02

Study Completion Date

2027-09-30

Brief Summary

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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.

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Detailed Description

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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

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Breast Cancer Lymphoma Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Cohort A

Prospective

Cardiac Imaging

Intervention Type DIAGNOSTIC_TEST

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

Cohort B

Retrospective/Prospective

Cardiac Imaging

Intervention Type DIAGNOSTIC_TEST

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

Data Collection

Intervention Type OTHER

Collection of retrospective data

Interventions

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Cardiac Imaging

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

Intervention Type DIAGNOSTIC_TEST

Data Collection

Collection of retrospective data

Intervention Type OTHER

Other Intervention Names

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Blood tests

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No