Early detection of heart and blood vessel damage from cancer treatments in children and young adults
Early Identification of Cardivascular Damage Induced by Chemotherapy and Antineoplastic Treatments in Pediatric Age
This project tests whether newer heart and vessel imaging and stiffness tests can find treatment-related damage earlier in children, adolescents, and young adult cancer patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 0 Years to 18 Years |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 5 sites (Bologna, Bologna and 4 other locations) |
| Trial ID | NCT07382141 on ClinicalTrials.gov |
What this trial studies
The study applies advanced cardiac and vascular diagnostics — including ultrasonography with speckle tracking, vascular stiffness measurement, cardiac MRI, and histologic studies — to children, adolescents, and young adults who receive antineoplastic therapy. Participants undergo pretreatment cardiovascular risk stratification and tailored follow-up based on that risk. The aim is to identify subclinical or early cardiotoxic changes that standard follow-up focused only on left ventricular systolic dysfunction may miss. Early identification would enable interventions to prevent progression to symptomatic heart disease.
Who should consider this trial
Good fit: Children, adolescents, and young adults with a diagnosis of cancer who need antineoplastic (chemotherapy or related) treatment are the intended participants.
Not a fit: Patients who are not receiving potentially cardiotoxic antineoplastic therapies, are outside the pediatric/young adult age range, or cannot undergo the required imaging tests (for example, MRI contraindications) are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could enable earlier detection of cardiotoxicity and allow personalized follow-up to prevent progression to overt heart disease.
How similar studies have performed: Advanced imaging and strain-based approaches have shown promise for early cardiotoxicity detection in adult cancer populations, but they are less well validated in pediatric and young adult patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of oncological pathology and need for antineoplastic treatment Exclusion Criteria: * None
Where this trial is running
Bologna, Bologna and 4 other locations
- IRCCS - AOU di Bologna -Policlinico di Sant'Orsola UOC Pediatria — Bologna, Bologna, Italy (Recruiting)
- IRCCS AOU di Bologna -Policlinico di Sant'Orsola UO Cardiochirurgia pediatrica e dell'età evolutiva — Bologna, Bologna, Italy (Recruiting)
- IRCCS AOU di Bologna -Policlinico di Sant'Orsola UO Oncoematologia Pediatrica — Bologna, Bologna, Italy (Recruiting)
- IRCCS AOU di Bologna Policlinico di Sant'Orsola UO Cardiologia Pediatria e dell'età evolutiva — Bologna, Bologna, Italy (Recruiting)
- IRCCS AOU di Bologna Policlinico di Sant'Orsola UO Radiologia, sezione Cardio-Toraco-Vascolare — Bologna, Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: Andrea Donti, MD
- Email: andrea.donti@aosp.bo.it
- Phone: 051/309900
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.