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

NCT07408362 | Not Yet Recruiting

• 1 other identifier: B7072025000104
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (7)

• EKG anomaly

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

  At inclusion (single study visit)

• Echocardiography anomaly: systolic dysfunction

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

  At inclusion (single study visit)

• Echocardiography anomaly: diastolic dysfunction

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

  At inclusion (single study visit)

• Echocardiography anomaly: Significant alteration in myocardial deformation

  GLS decrease \> 15%

  At inclusion (single study visit)

• Echocardiography anomaly: myocardial work indices

  abnormal Myocardial Work indices

  At inclusion (single study visit)

• Echocardiography anomaly: valvular disease or heart inflammation

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

  At inclusion (single study visit)

• Cardiopulmonary Exercise Testing (CPET): Impaired functional capacity

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

  At inclusion (single study visit)

Study Arms (1)

Pediatric Cancer Survivors in CHU Liege

EXPERIMENTAL

Patients aged 2 to 25 years followed at CHU de Liège, who have received potentially cardiotoxic treatment (chemotherapy and/or thoracic radiotherapy) for pediatric cancer or bone marrow transplantation since January 1st, 2016 and are in remission for at least 1 year.

Diagnostic Test: Ergospirometry

Interventions

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.

Also known as: Accelerometer Data, Biology sample, quality of life and physical activity validated evaluation forms

Pediatric Cancer Survivors in CHU Liege

Eligibility Criteria

• Age: 2 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Active disease recurrence or relapse.
• Current administration of antineoplastic therapy.
• Withdrawal of consent or refusal to participate by the patient or their legal representatives.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Liege: lead
• Centre Hospitalier Régional de la Citadelle: collaborator

MeSH Terms

Conditions

Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Caroline E M Jacquemart

CONTACT

+32 4 3218451; caroline.jacquemart@chuliege.be

Catherine Sondag

CONTACT

etudes.pediatrie@chuliege.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatrician, MD, Head of Clinic

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 13, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2033
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share