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

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.

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Key information

Conditions

Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Wounds and Injuries

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS - AOU di Bologna -Policlinico di Sant'Orsola UOC Pediatria, Bologna, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of oncological pathology and need for antineoplastic treatment

Exclusion criteria

None

Treatment and study plan

Parameters of vascular stiffness

Device

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 outcomes

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

Number 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Donti, MD

CONTACT

[email protected]

051/309900

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: PREDICT

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Feb 2, 2026
Registry last updated: Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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