Prediction of Delayed Toxic Cardiomyopathy in Children (SpeckleAnthra2)

University Hospital Center (CHU)

Status: Terminated

Conditions: Cardiotoxicity; Childhood Cancer

Treatments: Diagnostic Test: cardiac ultrasound with speckle tracking analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT05781672

RECHMPL22_0513

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 patients

Sex: All

Ages: 11 to 27 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

Anthra2

Experimental group

Description:

Patient will have an echocardiography with speckle tracking analysis 5 years after the end of their participation to "SpeckleAnthra" study (NCT02893787)

Treatment:

Diagnostic Test: cardiac ultrasound with speckle tracking analysis

Control

Active Comparator group

Description:

Cardiac ultrasound analysis with speckle tracking of age- and sex-matched healthy patients in the Anthra2 group

Treatment:

Diagnostic Test: cardiac ultrasound with speckle tracking analysis