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Early detection of acute and early-onset cardiovascuLar toxicity in children with cancer using a multiparametric approach.

Early detection of acute and early-onset cardiovascuLar toxicity in children with cancer using a multiparametric approach.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON22737
Enrollment
100
Registered
2019-08-23
Start date
2020-11-23
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Cancer

Interventions

None listed

Sponsors

Princess Maxima Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
1.Echocardiography systolic dysfunction at pretreatment, 3-4 months after start treatment and 1-year post start treatment: •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 10% from baseline measurement or to a value 15% decline in GLS from baseline measurement 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.

Contacts

Public ContactAnnelies Mavinkurve-Groothuis

Princess Maxima Center for pediatric oncology

a.m.c.mavinkurve-groothuis@prinsesmaximacentrum.nl06-50006531

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)