Early detection of acute and early-onset cardiovascuLar toxicity in children with cancer using a multiparametric approach.
- Conditions
- Childhood Cancer
- Registration Number
- NL-OMON22737
- Lead Sponsor
- Princess Maxima Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
In order to be eligible to participate in this study, a subject must meet all of the following criteria;
We will include 2 groups of CC patients in our study:
1)100 CC patients receiving anthracyclines as part of their cancer treatment in the Princess Máxima Center for Pediatric Oncology (group 1).
2)A subgroup of 30 CC patients aged > 8 years, diagnosed with HL, ES, OS or STS, receiving anthracyclines as part of their cancer treatment and will undergo MRI evaluation as part of their tumor response evaluation. (group 2).
All children and/or their parents will be asked for informed consent for cardiac screening with the described multimodality approach using echocardiography, ECG and future cardiac blood biomarkers and genetic testing. Patients who meet the inclusion criteria for group 2, will be asked for an additional informed consent to also undergo cardiac MRI.
A potential subject who meets any of the following criteria will be excluded from participation in this study:
Exclusion criteria are children with severe comorbidity (being too sick for evaluation), history of thoracic radiation or chemotherapy for other malignancies, general contraindications for MRI for the patients in the MRI study group. Patients who need anaesthesia for MRI scanning will be excluded from the study.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Echocardiography systolic dysfunction at pretreatment, 3-4 months after start treatment and 1-year post start treatment: <br>•A change in left ventricular ejection fraction (EF) (echocardiography), defined as a decline in EF of >10% from baseline measurement or a decrease to a value <50% or symptomatic heart failure <br>•A change in left ventricular fractional shortening (echocardiography), defined as a decline in fractional shortening of >10% from baseline measurement or to a value <28% or symptomatic heart failure<br>•A change in left ventricular global longitudinal strain (GLS) measurements (echocardiography), defined as >15% decline in GLS from baseline measurement<br>2.Presence of myocardial fibrosis (MRI) at pretreatment, 3-4 months after start treatment and 1-year post start treatment expressed by increased myocardial T1 values, ECV (extracellular volume), and/or delayed enhancement.
- Secondary Outcome Measures
Name Time Method