Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Bone Density Conservation Agents

Calcium

Calcium, Dietary

Cardiac imaging and circulating biomarkers measurements to evaluate:

* myocardial dysfunction and deformation (ECHO-ST)
* coronary artery lesions and coronary artery calcium score (CT)
* myocardium including tissue abnormalities, cardiac morphology and function (MRI)
* blood-based biomarkers of cardiovascular changes (BLOOD)

Automated 2D-speckle-tracking echocardiography (ECHO-ST); Computed tomography coronary angiography (CT); Cardiac magnetic resonance imaging (MRI); Blood samples for circulating biomarkers measurements (BLOOD)

Cardiac imaging and circulating biomarkers

Sophie Jacob, PhD

Breast cancer (BC) radiotherapy leads to coincidental radiation of the heart, resulting in increased risk of a variety of heart diseases. Identifying BC patients with the highest risk of radiation-induced cardiac complications is crucial for developing strategies for primary and secondary prevention. Little has been done on the relationship between dose distribution to different anatomical cardiac structures during radiotherapy and early cardiovascular changes that may lead to cardiac complications.

In the framework of the European project MEDIRAD, the EARLY-HEART multicenter prospective cohort was launched in August 2017, involving 5 investigating centers from France, Netherlands, Germany, Spain and Portugal. With 250 BC patients prospectively followed for 2 years, the main objective is to identify and validate the most important cardiac imaging (echocardiography, computed tomography coronary angiography, cardiac magnetic resonance imaging) and circulating biomarkers of radiation-induced cardiovascular changes arising in the first 2 years after BC radiotherapy.

EARLY-HEART is a multicentre prospective cohort study that will include 250 female primary breast cancer cases aged 40-75 years treated with postoperative radiotherapy (RT) alone after breast-conserving surgery using modern planning-CT based RT technologies and followed for 2 years after RT in one of the 5 participating hospitals. In addition to the standard follow-up, patients will need to give repeated blood samples and will undergo repeated cardiac imaging:

* Functional and anatomical cardiac imaging biomarkers will be based on automated 2D-speckle-tracking echocardiography (ECHO-ST); Computed Tomography Coronary Angiography (CT) and cardiac magnetic resonance imaging (MRI).
* Circulating biomarkers (BLOOD) will be based on a panel of multiple classical or novel blood-based biomarkers.

Imaging and circulating biomarkers measurements will be assessed at baseline before RT (ECHO, CT, MRI, BLOOD); at the end of RT (BLOOD); 6 months after RT (ECHO, MRI, BLOOD) and 24 months after RT (ECHO, CT, MRI, BLOOD).

Changes in functional and anatomical cardiac imaging and circulating biomarkers between unexposed status before RT and exposed status after RT at different time points will be first analysed to evaluate the effects of RT on the heart.

All relevant DICOM-data (including planning-CT scans and the ECHO, MRI and CT) will be centralized to the MEDIRAD-ENACT database managed by University of Groningen for automated segmentation of all cardiac substructures (including coronary arteries) to ensure uniformity of the segmentation procedure between centres. The RT planning CTs will be used to generate dose volume histograms and 3D dose maps of the heart and cardiac substructures in order to correlate the localization of any cardiovascular change with the anatomical dose distribution.

In the presence of a cardiac outcome, a multimetric Normal Tissue Complication Probability (NTCP) individual risk model will be constructed and an integrative clinical-biologic risk score will be developed for individual risk prediction.

Early Detection of Cardiovascular Changes After Radiotherapy for Breast Cancer

Early Detection of Cardiovascular Changes After Radiotherapy for Breast Cancer (EARLY HEART Study) in the Frame of the Implications of MEDIcal Low Dose RADiation Exposure (MEDIRAD) European Project

Number of patients with an increased of at least 2.5% in the Global Longitudinal Strain (GLS) between baseline and 2 years after radiotherapy

Increase of the segmental strain measurements (unit of measures:%)

Increase of the number of coronary segments containing any plaque or increase of the calcium score

Increase of the native mean myocardial T1 mapping value

Significant increase or decrease in the following biomarkers:

classical biomarkers of cardiac injury (C-reactive protein, Troponin I, Troponin T, B-type natriuretic peptide (BNP), N-terminal pro-brain natriuretic peptide (NT-Pro BNP), beta2-Microglobulin, Galectin 3); Inflammatory cytokines; biomarkers of endothelial activation and dysfunction; Microparticles; MicroRNAs; circulating DNA methylation

Academisch Ziekenhuis Groningen

Technical University of Munich

Institut Català d'Oncologia

Hospital de Santa Maria, Portugal

University of Paris 5 - Rene Descartes

Institut de Radioprotection et de Surete Nucleaire

Blood and Lymph Conditions

Immune System Diseases

Heart and Blood Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Rare Diseases

Lymphoma

Leukemia

Cardiotoxicity

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Lymphosarcoma

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

Cardiac Imaging

Data Collection

Jean-Claude Tardif, MD

Isabelle Cloutier, PhD

Hassan Saima, MD

Tkalec Lydia

Olivia Ienaro

Nicholas Meti, MD

Celine Nkoue

Luigina Mollica, MD

Chantal Lacoste

Jean-Claude Tardif, M.D

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.

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.

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

AstraZeneca

Montreal Heart Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Early Detection of Cardiovascular Changes After Radiotherapy for Breast Cancer	NCT03297346	Breast Cancer F...	Cardiac imaging...	40 Years - 75 Years	Institut de Radioprotection et de Surete Nucleaire
Early Detection of Cardiovascular Changes After Radiotherapy for Breast Cancer	NCT03297346	Breast Cancer F...	Cardiac imaging...	40 Years - 75 Years	Institut de Radioprotection et de Surete Nucleaire
Identification and Evaluation of Patients at Risk of Developing Cardiotoxicity After Receiving Chemotherapy for Breast Cancer, Lymphoma or Leukemia	NCT04541212	Breast Cancer Lymphoma Leukemia	Cardiac Imaging Data Collection	18 Years -	Montreal Heart Institute
Early Detection of Cardiovascular Changes After Radiotherapy for Breast Cancer	NCT03297346	Breast Cancer F...	Cardiac imaging...	40 Years - 75 Years	Institut de Radioprotection et de Surete Nucleaire

Spots Global Cancer Trial Database for cardiac imaging