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NCT Number: NCT07253077

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

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.

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Key information

Age range

6 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location contact

Alberto Romano, MD

SUB_INVESTIGATOR

Antonio Ruggiero, MD

CONTACT

[email protected]

+39 0630158305

Antonio Ruggiero, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

for the patient group:

  • 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.

Exclusion criteria

for the patient group:

  • disease remission for less than 1 year;
  • age less than 6 years at the time of enrollment;
  • presence of known comorbidities (cardiopulmonary diseases, neurological diseases, etc.).

Inclusion criteria

for the control group:

  • age at the time of enrollment: 6 years or older;
  • good health.

Exclusion criteria

for the control group:

  • having had oncological diseases;
  • having undergone thoracic radiotherapy;
  • having undergone anthracycline chemotherapy;
  • being under 6 years of age at the time of enrollment;
  • having known comorbidities (cardiopulmonary diseases, neurological diseases, etc.).

Treatment and study plan

Biomarker detection

Diagnostic Test

All patients will be tested for plasma levels of Serpin 3, THBS1, TGFbeta1, HIF1a, extracellular ICAM1, and endothelin.

In addition, the study will collect the following anamnestic data:

  • patient demographics, clinical data (age, sex, presence of comorbidities, medical history), instrumental data (echocardiogram performed), and laboratory data;
  • data relating to the neoplastic pathology and treatment performed

Primary outcomes

  1. To assess the possible presence of differences in the concentration of early biomarkers of "endothelial-mesenchymal transition" and endothelial damage between subjects treated with anthracycline therapy and healthy controls.

    Time frame: Biomarker assays will be performed only upon enrollment.

    Measurement of the concentration of biomarkers of endothelial-mesenchymal transition and endothelial damage (Serpin 3, THBS1, TGF-beta1, HIF1a, extracellular ICAM1, troponin, proBNP, fibrinogen, von Willebrand factor, endothelin) in patients who had recovered from cancer and underwent anthracycline therapy and compared with controls.

  2. To evaluate possible associations between measured biomarkers and echocardiogram results and medical history in subjects treated with anthracycline therapy.

    Time frame: Biomarkers and medical history will be collected at the moment of enrollement in the study

    Measurement of the linear correlation between biomarkers and the results obtained in the echocardiographic examination and the treatments performed.

Study contacts

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

Antonio Ruggiero, MD

CONTACT

[email protected]

+39 0630158305

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: CARDIO-PED

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 28, 2025
Registry last updated
Nov 28, 2025

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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