Evaluation of Cardiac and Endothelial Function in Children and Adolescents Treated With Anthracycline
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biomarker detection, Biomarker detection.
- Who it may be relevant to
- Registry conditions: Anthracycline Related Cardiotoxicity in Childhood Cancers, Chemotherapeutic Toxicity, Childhood Cancer Survivors. Basic parameters: 6 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Cardiac and Endothelial Function Measured by Laboratory Biomarkers and Echocardiographic and Endothelial Testing in Children and Adolescents Treated With Anthracyclines
Overview
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.
Interventions
- Diagnostic test Biomarker detection
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 - Diagnostic test Biomarker detection
All controls will be tested for plasma levels of Serpin 3, THBS1, TGFbeta1, HIF1a, extracellular ICAM1, and endothelin. In addition, the study will collect information on demographics, clinical data (age, sex, presence of comorbidities, medical history), instrumental data (echocardiogram performed), and laboratory data.
Primary outcome measures
- 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.]
- 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]
Eligibility criteria
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.).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma
Identifiers
NCT: NCT07253077 · 7304