Early Diagnosis and Cardiovascular Risk Stratification in Children Exposed to Cancer Therapies (CTRCT-pedia)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Childhood Cancer; Chemotherapeutic Toxicity; Radiotherapy Side Effect; Cardiovascular Complication; Cancer Therapy-related Cardiovascular Toxicity
• Intervention / Treatment: Diagnostic test: Ergospirometry

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caroline E M Jacquemart; Phone Number: +32 4 3218451; Email: caroline.jacquemart@chuliege.be
• Study Contact Backup: Name: Catherine Sondag; Phone Number: etudes.pediatrie@chuliege.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pediatric Cancer Survivors in CHU Liege; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Liege
• Collaborators: Centre Hospitalier Régional de la Citadelle

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2033

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Neoplasms; Radiation Injuries
• Other Study ID Numbers: B7072025000104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No