Investigating heart injury in children receiving anthracycline chemotherapy
Prediction of Cardiac Injury Due to Anthracycline Chemotherapy in Paediatric Oncological Patients Using Advanced Echocardiography and Circulating Biomarkers.
This study is testing if heart scans and blood tests can help doctors predict heart damage in children starting anthracycline chemotherapy for cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 22 (estimated) |
| Ages | 0 Years to 18 Years |
| Sex | All |
| Sponsor | IRCCS Burlo Garofolo Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Trieste, Italy) |
| Trial ID | NCT06898320 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on pediatric oncology patients who are about to start anthracycline chemotherapy. It aims to assess the role of echocardiography and serum biomarkers, such as NT-proBNP and cardiac Troponin-I, in predicting cardiac injury. The study recognizes the variability in patients' susceptibility to cardiotoxicity from anthracyclines and seeks to establish effective screening strategies to prevent long-term heart complications. By monitoring cardiac function before and during treatment, the study hopes to improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are pediatric oncology patients aged 0-18 years who are about to begin anthracycline therapy and have normal left ventricular function.
Not a fit: Patients who have previously received anthracycline treatment or have significant pre-existing cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better monitoring and prevention of heart failure in pediatric cancer survivors treated with anthracycline chemotherapy.
How similar studies have performed: Other studies have shown success in using echocardiography and biomarkers to monitor cardiac function in patients undergoing chemotherapy, suggesting this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Paediatric oncological patients 0-18 years * Planned start of anthracycline therapy * Normal left ventricular systolic function according to International Guidelines before the treatment with AC Exclusion Criteria: * Previous anthracycline treatment, bone marrow transplantation or chest radiation * Pre-anthracycline treatment echocardiographic evidence of: * More than mild pericardial effusion * More than mild mitral regurgitation * Poor echocardiographic acoustic window
Where this trial is running
Trieste, Italy
- IRCCS Burlo Garofolo — Trieste, Italy, Italy (Recruiting)
Study contacts
- Principal investigator: Thomas Caiffa, MD — IRCCS Burlo Garofolo
- Study coordinator: Thomas Caiffa, MD
- Email: thomas.caiffa@burlo.trieste.it
- Phone: +39 0403785248
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.