Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Therapy-related Cardiovascular Toxicity | — | UNRESOLVED | — |
| Cardiovascular Complication | — | UNRESOLVED | — |
| Chemotherapeutic Toxicity | — | UNRESOLVED | — |
| Childhood Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ergospirometry | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pediatric Cancer Survivors in CHU Liege
- description
- 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.
- interventionNames
- Diagnostic Test: Ergospirometry
Primary outcomes (7)
- measure
- EKG anomaly
- timeFrame
- At inclusion (single study visit)
- description
- Presence of arrhythmia, prolonged QTc interval, or conduction disorders.
- measure
- Echocardiography anomaly: systolic dysfunction
- timeFrame
- At inclusion (single study visit)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 25 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available