Anthracycline Related Cardiotoxicity in Childhood CancersCARDIO-PEDNCT07253077
Evaluation of Cardiac and Endothelial Function in Children and Adolescents Treated With Anthracycline
An observational study of Anthracycline Related Cardiotoxicity in Childhood Cancers and Chemotherapeutic Toxicity, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Anthracycline Related Cardiotoxicity in Childhood Cancers, Chemotherapeutic Toxicity, Childhood Cancer Survivors
- What is being tested?
- Biomarker detection
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2025to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The patient group will be selected among patients who have undergone anthracycline therapy and are undergoing regular follow-up at the Pediatric Oncology Unit of the Fondazione Policlinico Universitario A. Gemelli in Rome. Information about the tumor, treatments, and cardiac monitoring (echocardiogram) must be available for all patients. The control group will be selected from patients who visit the Pediatric Oncology Unit for a hematological evaluation but who have never undergone anthracycline therapy and have no known cardiac problems. All subjects (patients and controls) will undergo a thorough medical history and a clinical assessment, including a physical examination and measurement of vital signs and anthropometric parameters. Furthermore, all enrolled subjects, both patients and controls, will be required to collect, at a routine blood sampling time, a 6 ml tube for the measurement of biomarkers of endothelial-mesenchymal transition and endothelial activation.
Who may be able to join
- 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.
Who cannot join
- 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.).
- 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.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Antonio Ruggiero, MD, +39 0630158305, antonio.ruggiero@policlinicogemelli.it
Antonio Ruggiero, MD
About this study
Official title: Evaluation of Cardiac and Endothelial Function Measured by Laboratory Biomarkers and Echocardiographic and Endothelial Testing in Children and Adolescents Treated With Anthracyclines
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.
Read more
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.
- Conditions
- Anthracycline Related Cardiotoxicity in Childhood Cancers, Chemotherapeutic Toxicity, Childhood Cancer Survivors
- Being tested
- Biomarker detection
- Keywords
- Childhood cancer survivors, Anthracycline related cardiotoxicity, Chemotherapy long term side effects, Cancer survivor follow up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker detectionDiagnostic 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
Biomarker detectionDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with anthracyclines | Patients who recovered from cancers and who underwent treatment with anthracyclines (from January 2010 to November 2024) and are undergoing regular follow-up. Inclusion criteria for the patient group:
* diagnosis of hematologic oncology 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. Receives: Diagnostic Test: Biomarker detection | |
| Control group | Subjects never treated with anthracyclines and free of cancer. Inclusion criteria for the control group:
* Age at enrollment greater than or equal to 6 years;
* Good health. Receives: Diagnostic Test: Biomarker detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 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.
Measurement of the linear correlation between biomarkers and the results obtained in the echocardiographic examination and the treatments performed.
Measured: Biomarkers and medical history will be collected at the moment of enrollement in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anthracycline Related Cardiotoxicity in Childhood CancersStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Ruggiero, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253077
- Sponsor's protocol ID
- 7304
- Acronym
- CARDIO-PED
- Status last verified
- Oct 2025
- First submitted
- 19 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiac and Endothelial Function Measured by Laboratory Biomarkers and Echocardiographic and Endothelial Testing in Children and Adolescents Treated With Anthracyclines
- ClinicalTrials.gov ID
- NCT07253077
- Acronym / sponsor ID
- CARDIO-PED / 7304
- Conditions
- Anthracycline Related Cardiotoxicity in Childhood Cancers, Chemotherapeutic Toxicity, Childhood Cancer Survivors
- Keywords
- Childhood cancer survivors, Anthracycline related cardiotoxicity, Chemotherapy long term side effects, Cancer survivor follow up
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with anthracyclines | – | Diagnostic Test: Biomarker detectionPatients who recovered from cancers and who underwent treatment with anthracyclines (from January 2010 to November 2024) and are undergoing regular follow-up. Inclusion criteria for the patient group: * diagnosis of hematologic oncology 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. |
| Control group | – | Diagnostic Test: Biomarker detectionSubjects never treated with anthracyclines and free of cancer. Inclusion criteria for the control group: * Age at enrollment greater than or equal to 6 years; * Good health. |
Who may qualify
- Ages
- 6 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The patient group will be selected among patients who have undergone anthracycline therapy and are undergoing regular follow-up at the Pediatric Oncology Unit of the Fondazione Policlinico Universitario A. Gemelli in Rome. Information about the tumor, treatments, and cardiac monitoring (echocardiogram) must be available for all patients. The control group will be selected from patients who visit the Pediatric Oncology Unit for a hematological evaluation but who have never undergone anthracycline therapy and have no known cardiac problems. All subjects (patients and controls) will undergo a thorough medical history and a clinical assessment, including a physical examination and measurement of vital signs and anthropometric parameters. Furthermore, all enrolled subjects, both patients and controls, will be required to collect, at a routine blood sampling time, a 6 ml tube for the measurement of biomarkers of endothelial-mesenchymal transition and endothelial activation.
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- 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.).
- having had oncological diseases;
- having undergone thoracic radiotherapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarker detectionAll 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 | Patients treated with anthracyclines |
| Biomarker detectionAll 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. | Diagnostic test | Control group |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonio Ruggiero principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anthracycline Related Cardiotoxicity in Childhood Cancers and Chemotherapeutic Toxicity, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Ruggiero, MD (+39 0630158305, antonio.ruggiero@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.