Early Diagnosis and Cardiovascular Risk Stratification in Children Exposed to Cancer Therapies

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-25
SponsorCentre Hospitalier Universitaire de Liege

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Active disease recurrence or relapse.

Current administration of antineoplastic therapy.

Withdrawal of consent or refusal to participate by the patient or their legal representatives.

Trial design

Design model

Single group

Treatments tested in this trial

  • Ergospirometry

    Diagnostic test

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Pediatric Cancer Survivors in CHU LiegeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

EKG anomaly

Presence of arrhythmia, prolonged QTc interval, or conduction disorders.

Time frame
At inclusion (single study visit)
2

Echocardiography anomaly: systolic dysfunction

Systolic dysfunction: LVEF \< 55% or a relative decrease of \>15%.

Time frame
At inclusion (single study visit)
3

Echocardiography anomaly: diastolic dysfunction

Based on standardized pediatric values : * E/A ratioaverage * E/e' \> 14 * e' velocities * LA volume index \> 32 mL/m².

Time frame
At inclusion (single study visit)
4

Echocardiography anomaly: Significant alteration in myocardial deformation

GLS decrease \> 15%

Time frame
At inclusion (single study visit)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire de Liege

Lead sponsor

Centre Hospitalier Régional de la Citadelle

Collaborator

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