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NCT Number: NCT07408362

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

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.

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Key information

Conditions

Cancer Therapy-related Cardiovascular Toxicity Cardiovascular Complication Chemotherapeutic Toxicity Childhood Cancer Neoplasms Radiation Injuries Radiotherapy Side Effect Wounds and Injuries

Age range

2 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Accelerometer Data, Biology sample, quality of life and physical activity validated evaluation forms

Primary outcomes

  1. EKG anomaly

    Time frame: At inclusion (single study visit)

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

  2. Echocardiography anomaly: systolic dysfunction

    Time frame: At inclusion (single study visit)

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

  3. Echocardiography anomaly: diastolic dysfunction

    Time frame: At inclusion (single study visit)

    Based on standardized pediatric values :

    • E/A ratioaverage
    • E/e' > 14
    • e' velocities
    • LA volume index > 32 mL/m².

  4. Echocardiography anomaly: Significant alteration in myocardial deformation

    Time frame: At inclusion (single study visit)

    GLS decrease > 15%

  5. Echocardiography anomaly: myocardial work indices

    Time frame: At inclusion (single study visit)

    abnormal Myocardial Work indices

  6. Echocardiography anomaly: valvular disease or heart inflammation

    Time frame: At inclusion (single study visit)

    Structural/Inflammatory damage: Significant valvular disease, or signs of acute/chronic pericarditis and myocarditis.

  7. Cardiopulmonary Exercise Testing (CPET): Impaired functional capacity

    Time frame: At inclusion (single study visit)

    defined as peak VO2 < 85% or maximal workload < 85% of predicted theoretical values.

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline E M Jacquemart

CONTACT

[email protected]

+32 4 3218451

Catherine Sondag

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Liege

Other

Collaborators

  • Centre Hospitalier Régional de la Citadelle

Registry information

Official study title

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

Acronym: CTRCT-pedia

Important dates

Study start
2026
Primary completion
2028
Study completion
2033
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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