Early Identification of Cardivascular Damage Induced by Chemotherapy and Antineoplastic Treatments in Pediatric Age
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Parameters of vascular stiffness.
- Who it may be relevant to
- Registry conditions: Cardiotoxicity. Basic parameters: 0 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
To test whether the implementation of new diagnostic techniques (ultrasonography, speckle tracking, vascular stiffness study, cardiac MRI, and histologic studies) allows in CAYA (Childern, Adolescents, and Young Adults) cancer survivors a more sensitive and earlier identification of cardiovascular damage resulting from antineoplastic therapy that develops either acutely or remotely after completion of antineoplastic therapy.
Detailed description
Cardiovascular system is among the main target organs of toxicity of some antineoplastic treatments. Pretreatment cardiotoxicity risk stratification and timing tailored to patient needs are strategies recognized in cardiology but not yet well validated in the pediatric population. Currently, follow-up of the pediatric patient diagnosed with oncologic disease involves serious cardiologic evaluation, independent of cardiovascular risk factors and focused on recognition of left ventricular systolic dysfunction. The use of new diagnostic methods to study the pediatric patient exposed to antineoplastic therapy and the personalization of follow-up on the basis of pretreatment cardiovascular risk could allow early identification of cardiotoxic damage and thus prevent its progression.
Interventions
- Device Parameters of vascular stiffness
VICORDER© is a noninvasive, quick and painless technique to be able to assess vascular elasticity and consists of placing a few sphygmomanometers (the same ones used to measure blood pressure) for a few minutes
Primary outcome measures
- Incidence of cardiovascular events in CAYA cancer survivors during treatment and follow-up [Time frame: From initiation of antineoplastic therapy up to 12 months post-therapy]
Eligibility criteria
Inclusion criteria
- Diagnosis of oncological pathology and need for antineoplastic treatment
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Italy · 5 centers
- IRCCS - AOU di Bologna -Policlinico di Sant'Orsola UOC Pediatria — Bologna
- IRCCS AOU di Bologna -Policlinico di Sant'Orsola UO Cardiochirurgia pediatrica e dell'età — Bologna
- IRCCS AOU di Bologna -Policlinico di Sant'Orsola UO Oncoematologia Pediatrica — Bologna
- IRCCS AOU di Bologna Policlinico di Sant'Orsola UO Cardiologia Pediatria e dell'età evolut — Bologna
- IRCCS AOU di Bologna Policlinico di Sant'Orsola UO Radiologia, sezione Cardio-Toraco-Vasco — Bologna
Identifiers
NCT: NCT07382141 · PRE.D.I.C.T.