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

How to Improve Early Diagnosis and Cardiovascular Risk Stratification in Children Exposed to Chemotherapy and/or Thoracic Radiotherapy? Multimodal Cardiological Evaluation and Biomarkers.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07408362
Acronym
CTRCT-pedia
Enrollment
100
Registered
2026-02-13
Start date
2026-02-15
Completion date
2033-12-31
Last updated
2026-02-13

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

Conditions

Cancer Therapy-related Cardiovascular Toxicity, Cardiovascular Complication, Chemotherapeutic Toxicity, Childhood Cancer, Radiotherapy Side Effect

Brief summary

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_TESTErgospirometry

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.

Sponsors

Centre Hospitalier Universitaire de Liege
Lead SponsorOTHER
Centre Hospitalier Régional de la Citadelle
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 25 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
EKG anomalyAt inclusion (single study visit)Presence of arrhythmia, prolonged QTc interval, or conduction disorders.
Echocardiography anomaly: systolic dysfunctionAt inclusion (single study visit)Systolic dysfunction: LVEF \< 55% or a relative decrease of \>15%.
Echocardiography anomaly: diastolic dysfunctionAt inclusion (single study visit)Based on standardized pediatric values : * E/A ratioaverage * E/e' \> 14 * e' velocities * LA volume index \> 32 mL/m².
Echocardiography anomaly: Significant alteration in myocardial deformationAt inclusion (single study visit)GLS decrease \> 15%
Echocardiography anomaly: myocardial work indicesAt inclusion (single study visit)abnormal Myocardial Work indices
Echocardiography anomaly: valvular disease or heart inflammationAt inclusion (single study visit)Structural/Inflammatory damage: Significant valvular disease, or signs of acute/chronic pericarditis and myocarditis.
Cardiopulmonary Exercise Testing (CPET): Impaired functional capacityAt inclusion (single study visit)defined as peak VO2 \< 85% or maximal workload \< 85% of predicted theoretical values.

Contacts

CONTACTCaroline E M Jacquemart
caroline.jacquemart@chuliege.be+32 4 3218451
CONTACTCatherine Sondag
etudes.pediatrie@chuliege.be

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026