Actively Recruiting

Phase Not Applicable
Age: 0Years - 18Years
All Genders
ID07382141

Early Identification of Cardiovascular Damage Induced by Chemotherapy and Antineoplastic Treatments in Children, Adolescents, and Young Adults

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2026-02-02

400

Participants Needed

5

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates whether new diagnostic techniques can detect heart damage earlier and more sensitively in children, adolescents, and young adults (CAYA) who have survived cancer. It focuses on identifying cardiovascular harm caused by chemotherapy and other antineoplastic treatments, which may appear during or long after therapy completion. The study highlights the need to improve heart health monitoring in young cancer survivors using advanced tools. Participants will undergo evaluations using new methods such as ultrasonography, speckle tracking, vascular stiffness assessment with the VICORDER4 device, cardiac MRI, and histologic studies. These techniques aim to better identify early cardiovascular damage compared to current follow-up methods that mainly look for left ventricular dysfunction. The study emphasizes personalizing monitoring based on patients' cardiovascular risk before treatment. During the study, participants will be closely monitored from the start of their antineoplastic therapy through at least 12 months after treatment ends. Researchers will assess the incidence of cardiovascular events using these advanced diagnostic tools. The study involves painless, noninvasive procedures like vascular elasticity measurements with sphygmomanometers, imaging, and tissue analysis to track heart health and detect any damage early.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of oncological pathology and need for antineoplastic treatment
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - From initiation of antineoplastic therapy up to 12 months post-therapy

Participants undergo noninvasive assessments of vascular stiffness using VICORDER© to evaluate cardiovascular health before and during antineoplastic therapy.

Multiple visits during treatment and follow-up up to 12 months post-therapy

Trial Site Locations

Total: 5 locations

1

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

Bologna, Bologna, Italy, 40138

Actively Recruiting

2

IRCCS AOU di Bologna -Policlinico di Sant'Orsola UO Cardiochirurgia pediatrica e dell'età evolutiva

Bologna, Bologna, Italy, 40138

Actively Recruiting

3

IRCCS AOU di Bologna -Policlinico di Sant'Orsola UO Oncoematologia Pediatrica

Bologna, Bologna, Italy, 40138

Actively Recruiting

4

IRCCS AOU di Bologna Policlinico di Sant'Orsola UO Cardiologia Pediatria e dell'età evolutiva

Bologna, Bologna, Italy, 40138

Actively Recruiting

5

IRCCS AOU di Bologna Policlinico di Sant'Orsola UO Radiologia, sezione Cardio-Toraco-Vascolare

Bologna, Bologna, Italy, 40138

Actively Recruiting

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Research Team

A

Andrea Donti, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

0

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