How to Improve Early Diagnosis and Cardiovascular Risk Stratification in Children Exposed to Chemotherapy and/or Thoracic Radiotherapy? Multimodal Cardiological Evaluation and Biomarkers.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- EKG anomaly
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of chemotherapy and/or radiotherapy for an oncological condition or bone marrow transplantation (hematologic disease) after 01/01/
- •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.
排除标准
- •Active disease recurrence or relapse.
- •Current administration of antineoplastic therapy.
- •Withdrawal of consent or refusal to participate by the patient or their legal representatives.
研究组 & 干预措施
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.
干预措施: Ergospirometry (Diagnostic Test)
结局指标
主要结局
EKG anomaly
时间窗: At inclusion (single study visit)
Presence of arrhythmia, prolonged QTc interval, or conduction disorders.
Echocardiography anomaly: systolic dysfunction
时间窗: At inclusion (single study visit)
Systolic dysfunction: LVEF \< 55% or a relative decrease of \>15%.
Echocardiography anomaly: diastolic dysfunction
时间窗: At 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 deformation
时间窗: At inclusion (single study visit)
GLS decrease \> 15%
Echocardiography anomaly: myocardial work indices
时间窗: At inclusion (single study visit)
abnormal Myocardial Work indices
Echocardiography anomaly: valvular disease or heart inflammation
时间窗: At inclusion (single study visit)
Structural/Inflammatory damage: Significant valvular disease, or signs of acute/chronic pericarditis and myocarditis.
Cardiopulmonary Exercise Testing (CPET): Impaired functional capacity
时间窗: At inclusion (single study visit)
defined as peak VO2 \< 85% or maximal workload \< 85% of predicted theoretical values.
次要结局
未报告次要终点
研究者
Caroline Jacquemart
Pediatrician, MD, Head of Clinic
Centre Hospitalier Universitaire de Liege