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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07382141
Acronym
PREDICT
Enrollment
400
Registered
2026-02-02
Start date
2025-03-17
Completion date
2028-12-31
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiotoxicity

Keywords

cardiotoxicity

Brief summary

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

DEVICEParameters 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

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosis of oncological pathology and need for antineoplastic treatment

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Incidence of cardiovascular events in CAYA cancer survivors during treatment and follow-upFrom initiation of antineoplastic therapy up to 12 months post-therapyNumber of cardiovascular events, defined according to ESC 2022 guidelines (Eur Heart J. 2022;43:4229-4361), detected during treatment and follow-up. Time to occurrence of events will be measured relative to pre-treatment evaluation.

Countries

Italy

Contacts

CONTACTAndrea Donti, MD
andrea.donti@aosp.bo.it051/309900

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026