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

January 26, 2026 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Bologna
      • Bologna, Bologna, Italy, 40138
        • Recruiting
        • IRCCS - AOU di Bologna -Policlinico di Sant'Orsola UOC Pediatria
        • Contact:
        • Principal Investigator:
          • Marcello Lanari, MD
      • Bologna, Bologna, Italy, 40138
        • Recruiting
        • IRCCS AOU di Bologna -Policlinico di Sant'Orsola UO Cardiochirurgia pediatrica e dell'età evolutiva
        • Contact:
        • Principal Investigator:
          • Francesco Dimitri Petridis, MD
      • Bologna, Bologna, Italy, 40138
        • Recruiting
        • IRCCS AOU di Bologna -Policlinico di Sant'Orsola UO Oncoematologia Pediatrica
        • Principal Investigator:
          • Arcangelo Prete, MD
        • Contact:
      • Bologna, Bologna, Italy, 40138
        • Recruiting
        • IRCCS AOU di Bologna Policlinico di Sant'Orsola UO Cardiologia Pediatria e dell'età evolutiva
        • Contact:
        • Principal Investigator:
          • Andrea Donti, MD
      • Bologna, Bologna, Italy, 40138
        • Recruiting
        • IRCCS AOU di Bologna Policlinico di Sant'Orsola UO Radiologia, sezione Cardio-Toraco-Vascolare
        • Contact:
        • Principal Investigator:
          • Fabio Niro, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of oncological pathology and need for antineoplastic treatment

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From initiation of antineoplastic therapy up to 12 months post-therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

January 26, 2026

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRE.D.I.C.T.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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