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New study aims to predict heart side effects in kids treated for cancer

NCT ID NCT07253077

Knowledge-focused Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will check if certain blood markers can predict heart damage in children and teens who had anthracycline chemotherapy for cancer. Researchers will compare blood tests and heart imaging results from 40 survivors and healthy volunteers. The goal is to find early warning signs before heart problems develop.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

6 to 35 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.).

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Conditions

The condition(s) this trial relates to.

cardiomyopathy due to anthracyclines chemotherapy-induced toxicity childhood malignant neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anthracycline related cardiotoxicity in childhood cancers Chemotherapeutic toxicity Childhood cancer survivors

How to take part

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  1. The places running it

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  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.