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Early Identification of Cardivascular Damage Induced by Chemotherapy and Antineoplastic Treatments in Pediatric Age (PREDICT)

S

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status

Enrolling

Conditions

Cardiotoxicity

Treatments

Device: Parameters of vascular stiffness

Study type

Interventional

Funder types

Other

Identifiers

NCT07382141
PRE.D.I.C.T.

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of oncological pathology and need for antineoplastic treatment

Exclusion criteria

  • None

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

Single Blind

Trial contacts and locations

5

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Central trial contact

Andrea Donti, MD

Data sourced from clinicaltrials.gov

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