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Trial Title:
Prediction of Delayed Toxic Cardiomyopathy in Children
NCT ID:
NCT05781672
Condition:
Cardiotoxicity
Childhood Cancer
Conditions: Official terms:
Cardiomyopathies
Cardiotoxicity
Conditions: Keywords:
Echocardiography
Ventricular function
Stroke Volume
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
cardiac ultrasound with speckle tracking analysis
Description:
Experimental group: cardiac ultrasound with speckle tracking analysis done during a
regular cardiac visit planned after receiving cardiotoxic chemotherapy in childhood.
Control group: cardiac ultrasound with speckle tracking analysis done during a cardiac
visit for minor symptoms (murmur, physical aptitude).
Advocated Tomtec software will be used to make post-processing speckle tracking analysis
based on 2D ultrasound cineloop acquired during a standard echocardiography.
Arm group label:
Anthra2
Arm group label:
Control
Summary:
Longitudinal analysis of myocardial function using "Speckle Tracking Echocardiography"
STE analysis and prediction of delayed toxic induced cardiomyopathy in young patients who
received anthracycline therapy in childhood.
Detailed description:
Anthracycline therapy may have short-, medium- or long-term cardiac toxicity that impacts
patient's life. The main recognized risk factors for delayed cardiotoxicity are
cumulative anthracycline dose, female gender, association with mediastinal radiotherapy
and young age at administration. Prediction of delayed cardiotoxicity in children
population is still challenging.
The "Speckle Tracking Echocardiography" (STE) method, an innovative echocardiographic
technique, analyses the myocardial displacement of natural acoustic markers via a
software. The objective of the study is to analyze, in young patients who received
anthracycline therapy in childhood, 5-years after their inclusion in the "Speckle Anthra"
study and first STE results, the evolution of myocardial function using STE method.
Criteria for eligibility:
Criteria:
ANTHRA GROUP
Inclusion Criteria:
- Patients who were treated with anthracyclines for malignant disease between the ages
of 0 and 18
- Patient aged 11 to 27 years
- Included in the "SpeckleAnthra" Study (NCT02893787)
- Discontinued chemotherapy for more than 6 years
- Patient in remission of malignant disease
- Enrolled in a social security plan
- Written informed consent from at least one legal representative for the minor
patient/ Written informed consent for patients of legal age
Exclusion Criteria:
- Onset of active malignancy or recurrence of malignancy after the "Speckle Anthra"
study that required resumption of chemotherapy or mediastinal radiotherapy.
- Chronic cardiac, pulmonary or muscular pathology of etiology other than secondary to
anthracycline therapy
- For adult patients: subject under guardianship or curators
CONTROL GROUP
Inclusion Criteria:
- Control patient included in the "Speckle Control" study (NCT02056925)
- Had a cardiological consultation with echocardiography performed for a banal reason
(heart murmur test, cardiological symptoms) and whose result was normal
- No chronic disease or long-term drug treatment
Exclusion Criteria:
- Refusal to participate in the study by the patient and/or parents or legal guardian
after receipt of the study's information and non-objection note.
Gender:
All
Minimum age:
11 Years
Maximum age:
27 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
Address:
City:
Montpellier
Zip:
34295
Country:
France
Status:
Recruiting
Contact:
Last name:
Marie VINCENTI, MD, PhD
Phone:
0467336635
Email:
m-vincenti@chu-montpellier.fr
Start date:
March 16, 2023
Completion date:
September 30, 2025
Lead sponsor:
Agency:
University Hospital, Montpellier
Agency class:
Other
Source:
University Hospital, Montpellier
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05781672
