Early Diagnosis and Cardiovascular Risk Stratification in Children Exposed to Cancer Therapies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ergospirometry.
- Who it may be relevant to
- Registry conditions: Cancer Therapy-related Cardiovascular Toxicity, Childhood Cancer, Chemotherapeutic Toxicity, Radiotherapy Side Effect. Basic parameters: 2 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
How to Improve Early Diagnosis and Cardiovascular Risk Stratification in Children Exposed to Chemotherapy and/or Thoracic Radiotherapy? Multimodal Cardiological Evaluation and Biomarkers.
Overview
The goal of this prospective interventional study is to improve the detection of subclinical chronic Cancer Therapy-Related Cardiovascular Toxicity (CTRCT) and evaluate the added value of advanced cardioechography, ergospirometry, and specific biomarkers in pediatric cancer survivors (aged 2 to 25) who received potentially cardiotoxic treatments (chemotherapy/thoracic radiotherapy). The main questions it aims to answer are: * Can advanced echocardiography (including strain and myocardial work), ECG, and ergospirometry effectively diagnose earlier subclinical cardiac impairment in this population? * What is the prevalence of cardiovascular risk factors (including physical activity levels and biological markers like proBNP/troponins) * Can new genetic or biological markers be identified to help optimizing the detection of CTRCT? At time of follow-up, if they agree, participants will: * Complete validated questionnaires regarding quality of life, physical activity, and sedentary behavior. * Undergo a cardiopulmonary exercise test (ergospirometry) for those aged over 8 years. * Wear an accelerometer (ActiGraph GT3X) for 7 consecutive days to monitor physical activity. * Provide an additional blood sample during routine follow-up for the creation of a biobank dedicated to analyzing markers of senescence, fibrosis, apoptosis, and genetic polymorphisms.
Interventions
- Diagnostic test Ergospirometry
Completion of validated, age-appropriate quality of life scales and physical activity assessment forms. Patients over 8 years of age will perform a standardized cardiopulmonary exercise test (CPET / ergospirometry) on a treadmill. Seven-day continuous monitoring using a wearable accelerometer. Collection of a 10 mL blood sample (one EDTA tube and one serum-clotting tube), to be centrifuged and stored at -80°C in the CHU de Liège "BHUL" biobank.
Primary outcome measures
- EKG anomaly [Time frame: At inclusion (single study visit)]
- Echocardiography anomaly: systolic dysfunction [Time frame: At inclusion (single study visit)]
- Echocardiography anomaly: diastolic dysfunction [Time frame: At inclusion (single study visit)]
- Echocardiography anomaly: Significant alteration in myocardial deformation [Time frame: At inclusion (single study visit)]
- Echocardiography anomaly: myocardial work indices [Time frame: At inclusion (single study visit)]
- Echocardiography anomaly: valvular disease or heart inflammation [Time frame: At inclusion (single study visit)]
- Cardiopulmonary Exercise Testing (CPET): Impaired functional capacity [Time frame: At inclusion (single study visit)]
Eligibility criteria
Inclusion criteria
- History of chemotherapy and/or radiotherapy for an oncological condition or bone marrow transplantation (hematologic disease) after 01/01/2016.
- Age < 18 years at the time of treatment.
- Cancer remission for more than one year.
- Voluntary participation following comprehensive informed consent.
- Signed informed consent from the patient (≥ 18 years) or from parents/legal guardians, with signed assent for minors aged 8 to 17.
Exclusion criteria
- Active disease recurrence or relapse.
- Current administration of antineoplastic therapy.
- Withdrawal of consent or refusal to participate by the patient or their legal representatives.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07408362 · B7072025000104