NCT06898320

Brief Summary

The study investigates the role of echocardiography and of serum biomarkers (NT-proBNP, cardiac Troponin-I) in predicting cardiac injury in a cohort of paediatric oncological patients treated with Anthracycline chemotherapy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
88mo left

Started Jul 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress28%
Jul 2023Jul 2033

Study Start

First participant enrolled

July 21, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2025

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2033

Last Updated

May 9, 2025

Status Verified

May 1, 2025

Enrollment Period

10 years

First QC Date

March 20, 2025

Last Update Submit

May 6, 2025

Conditions

Heart InjuriesAnthracycline

Keywords

Cardiac injuryAnthracycline chemotherapyechocardiographyCirculating biomarkers

Outcome Measures

Primary Outcomes (2)

  • Sensitivity of change in myocardial work values 1 month after first Anthracycline chemotherapy treatment in predicting a decrease of the ejection fraction at 12 months

    Patients will be evaluated with a complete echocardiogram, registering ejection fraction (EF) and myocardial work (MW) before the start of Anthracycline chemotherapy (AC) treatment and 1 and 12 months after first AC treatment. A Receiver operating characteristic (ROC) Curve will be constructed to evaluate the sensitivity of the myocardial work (MW) change in predicting a decrease in ejection fraction (EF). Youden index will be calculated to find the optimum value of the myocardial work (MW) discriminating the decrease or not of ejection fraction (EF).

    12 months after first Anthracycline chemotherapy treatment

  • Sensitivity of change in myocardial work values 6 months after first Anthracycline chemotherapy treatment in predicting a decrease of the ejection fraction at 12 months

    Patients will be evaluated with a complete echocardiogram, registering ejection fraction (EF) and myocardial work (MW) before the start of Anthracycline chemotherapy (AC) treatment and 6 and 12 months after first Anthracycline chemotherapy (AC) treatment. A Receiver operating characteristic (ROC) Curve will be constructed to evaluate the sensitivity of the myocardial work (MW) change in predicting a decrease in ejection fraction (EF). Youden index will be calculated to find the optimum value of the myocardial work (MW) discriminating the decrease or not of ejection fraction (EF).

    12 months after first Anthracycline chemotherapy treatment

Secondary Outcomes (2)

  • Sensitivity of change in myocardial work values 1 month after first Anthracycline chemotherapy treatment combined with Troponin-I hs and NT-proBNP biomarkers in predicting a decrease of the ejection fraction at 12 months

    12 months after first Anthracycline chemotherapy treatment

  • Sensitivity of change in myocardial work values 6 months after first Anthracycline chemotherapy treatment combined with Troponin-I hs and NT-proBNP biomarkers in predicting a decrease of the ejection fraction at 12 months

    12 months after first Anthracycline chemotherapy treatment

Study Arms (1)

Anthracycline therapy

Paediatric oncological patients receiving anthracycline chemotherapy

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Paediatric oncological patients between 0 and 18 years with planned anthracycline therapy

You may qualify if:

  • Paediatric oncological patients 0-18 years
  • Planned start of anthracycline therapy
  • Normal left ventricular systolic function according to International Guidelines before the treatment with AC

You may not qualify if:

  • Previous anthracycline treatment, bone marrow transplantation or chest radiation
  • Pre-anthracycline treatment echocardiographic evidence of:
  • More than mild pericardial effusion
  • More than mild mitral regurgitation
  • Poor echocardiographic acoustic window

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Burlo Garofolo

Trieste, Italy, 34137, Italy

RECRUITING

MeSH Terms

Conditions

Heart Injuries

Condition Hierarchy (Ancestors)

Thoracic InjuriesWounds and Injuries

Study Officials

  • Thomas Caiffa, MD

    IRCCS Burlo Garofolo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Caiffa, MD

CONTACT

+39 0403785248thomas.caiffa@burlo.trieste.it

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2025

First Posted

March 27, 2025

Study Start

July 21, 2023

Primary Completion (Estimated)

July 21, 2033

Study Completion (Estimated)

July 21, 2033

Last Updated

May 9, 2025

Record last verified: 2025-05

Locations

IT(1)