The EARLY study: Early detection of acute and early-onset cARdiovascuLar toxicitY in children with cancer using a multiparametric approach.

The EARLY study: Early detection of acute and early-onset cARdiovascuLar toxicitY in children with cancer using a multiparametric approach. - The EARLY study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49327

Enrollment

100

Registered

2020-02-05

Start date

2020-11-26

Completion date

Unknown

Last updated

2026-08-10

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

Conditions

cardiomyopathy heart failure

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1) 100 children with cancer receiving anthracyclines according to their treatment protocol 2) A subgroup of 30 children, aged > 8 years, diagnosed with Hodgkin Lymphoma, Ewing Sarcoma, Osteosarcoma or Soft Tissue Sarcoma who have MRI evaluation as part of their tumor response evaluation. 3) a signed informed consent

Exclusion criteria

Exclusion criteria: Children with 1) severe comorbidity 2) congenital heart disease 3) a history of thoracic radiation or chemotherapy for other malignancies 4) general contraindications for MRI for the patients in the MRI study group. 5) Patients who need anaesthesia for MRI scanning

Design outcomes

Primary

Measure	Time frame
Outcome definitions for the pilot study 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 and/or ECV (extracellular volume).	—

Measure

Time frame

Outcome definitions for the pilot study 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 and/or ECV (extracellular volume).

—

Secondary

Measure	Time frame
1. Abnormal blod biomarkers pretreatment, after 3-4 months of treatment, 1 year after start of treatment 2. ECG abnormalities pretreatment, after 3-4 months of treatment, 1 year after start of treatment	—

Countries

Netherlands

Outcome results