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NCT07253077Not yet recruiting

Evaluation of Cardiac and Endothelial Function in Children and Adolescents Treated With Anthracycline

Evaluation of Cardiac and Endothelial Function Measured by Laboratory Biomarkers and Echocardiographic and Endothelial Testing in Children and Adolescents Treated With Anthracyclines

Source: ClinicalTrials.gov · Last updated 28 Nov 2025

Brief summary (registry, in English)

In recent decades, the survival rate of children with cancer has increased significantly thanks to personalized treatments and the adoption of international therapeutic protocols. However, along with this increase in survival, side effects related to these treatments on various organs and systems have been observed. Among the most widely used chemotherapeutic agents in pediatric age, anthracyclines play a crucial role in the treatment of various forms of neoplasms (both haematological such as acute lymphoblastic leukemia or lymphomas, and solid tumors such as sarcomas). However, in addition to their excellent antineoplastic effect, they are burdened by the potential for cardiotoxicity. This cardiotoxicity manifests clinically with left ventricular systolic dysfunction and arrhythmias. At the moment, international guidelines recommend long-term cardiac follow-up evaluations for this group of patients, even after treatment has concluded.The methods used in the cardiac follow-up of patients undergoing anthracycline therapy include echocardiography, cardiac magnetic resonance imaging, tests to assess endothelial function, and measurements of the biomarkers troponin and atrial natriuretic peptide. These methods can assess anthracycline-induced cardiac and endothelial damage once it has already occurred, but they cannot predict its onset nor can they study its pathogenesis. Furthermore, to date, no information is available regarding the possibility of using "endothelial-mesenchymal transition" biomarkers as predictors of the onset of anthracycline-induced cardiac damage. This study analyzes these biomarkers as predictive tools for cardiac damage. Specifically, plasma levels of Serpin 3, THBS1, TGFbeta1, HIF1a, extracellular ICAM1, troponin, proBNP, fibrinogen, von Willebrand factor, and endothelin will be measured in patients treated with anthracycline. The concentrations of these biomarkers will be compared with the results of the echocardiogram and with the treatments performed in order to identify any relationships. Furthermore, plasma levels of Serpin 3, THBS1, TGFbeta1, HIF1a, extracellular ICAM1, troponin, proBNP, fibrinogen, von Willebrand factor, and endothelin will also be measured in a population of healthy subjects in order to obtain data on a possible relationship between the biomarkers and the anthracycline therapies performed.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
40 (estimated)
First submitted
19 Nov 2025
Start date
Nov 2025
Primary completion date
Jan 2027
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NCT number
NCT07253077

What you commit to

  • Study type: Observational
  • Planned participants: 40
  • From Nov 2025 to the primary completion date, Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • having undergone thoracic radiotherapy;
  • having undergone anthracycline chemotherapy;

Other illness

  • disease remission for less than 1 year;
  • presence of known comorbidities (cardiopulmonary diseases, neurological diseases, etc.).
  • having had oncological diseases;
  • having known comorbidities (cardiopulmonary diseases, neurological diseases, etc.).

Age

  • age less than 6 years at the time of enrollment;
  • being under 6 years of age at the time of enrollment;

Who the study is looking for

  • diagnosis of cancer during childhood (diagnosis made between 0 and 16 years of age);
  • age at enrollment greater than or equal to 6 years;
  • having received anthracycline chemotherapy;
  • disease remission for at least 1 year;
  • absence of known cardiac disease prior to anthracycline therapy;
  • absence of congenital heart disease.
  • age at the time of enrollment: 6 years or older;
  • good health.

Age in the registry: 6 years to 35 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Coordinator of this site? Confirm its status
RomaItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.