CardiotoxicitySpeckleAnthra2NCT05781672
Prediction of Delayed Toxic Cardiomyopathy in Children
A study testing cardiac ultrasound with speckle tracking analysis in people with Cardiotoxicity and Childhood Cancer, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiotoxicity, Childhood Cancer
- What is being tested?
- cardiac ultrasound with speckle tracking analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2023to 7 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 11 to 27 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Show all 10Show fewer
- Written informed consent from at least one legal representative for the minor patient/ Written informed consent for patients of legal age
- 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
Who cannot join
- 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
- 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 locations and contacts
1 site in 1 country.
France1 site
Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
Montpellier, 34295
About this study
Official title: Longitudinal Analysis of Myocardial Function by Speckle Tracking Echocardiography and Prediction of Delayed Toxic Cardiomyopathy Associated With Anthracycline Therapy in Children
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.
Read the 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.
- Conditions
- Cardiotoxicity, Childhood Cancer
- Being tested
- cardiac ultrasound with speckle tracking analysis
- Keywords
- Echocardiography, Ventricular function, Stroke Volume
- Medical subject headings
- Cardiotoxicity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac ultrasound with speckle tracking analysisDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Anthra2 | Experimental | Patient will have an echocardiography with speckle tracking analysis 5 years after the end of their participation to "SpeckleAnthra" study (NCT02893787) Receives: Diagnostic Test: cardiac ultrasound with speckle tracking analysis |
| Control | Active comparator | Cardiac ultrasound analysis with speckle tracking of age- and sex-matched healthy patients in the Anthra2 group Receives: Diagnostic Test: cardiac ultrasound with speckle tracking analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricle Global Longitudinal 2D strain (LVGLS) expressed in percentage and obtained from cardiac ultrasound cineloop of 2D 4,3 and 2 apical views analyzed by the Tomtec STE Software.
To compare the evolution at 5 years ("Anthra2" study timeframe) of LVGLS obtained by STE analysis on patients treated with anthracyclines in childhood and previously included in first "Speckle Anthra" study, with the normal evolution of this parameter with age in healthy matched volunteers.
Measured: 5 years
Secondary outcomes (3)
Left Ventricle Ejection fraction (LVEF) by Simpson method (%)
Compare the standard ultrasound parameter LVEF and the LVGLS obtained in "Speckle Anthra 2" on patients treated with anthracyclines in childhood and in the group of healthy volunteers.
Measured: The day of inclusion
Left ventricular myocardial dysfunction defined by LVEF < 55%
Correlation between the left ventricular myocardial dysfunction is defined by FeVG < 55% and the left global longitudinal 2D strain expressed in percentage and measured during the previous SpeckleAnthra study
Measured: 5 years
Death secondary to toxic cardiomyopathy
Correlation between the rate of patients died with a toxic cardiomyopathy and the left global longitudinal 2D strain expressed in percentage and measured during the previous SpeckleAnthra study
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start16 Mar 2023
- Primary completion7 Jan 2025
- Study completion7 Jan 2025
Why it stopped: Analyses will be performed with data from included patients until the end of the inclusion period. The clinical team did not wish to extend the inclusion period in order not to delay the analyses.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- VINCENTI Marie, PH, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781672
- Sponsor's protocol ID
- RECHMPL22_0513
- Acronym
- SpeckleAnthra2
- Status last verified
- Feb 2025
- First submitted
- 27 Feb 2023
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: sharing of results after obtaining
Publications
Amedro P, Vincenti M, Abassi H, Lanot N, De La Villeon G, Guillaumont S, Gamon L, Mura T, Lopez-Perrin K, Haouy S, Sirvent A, Cazorla O, Vergely L, Lacampagne A, Avesani M, Sirvent N, Saumet L. Use of speckle tracking echocardiography to detect late anthracycline-induced cardiotoxicity in childhood cancer: A prospective controlled cross-sectional study. Int J Cardiol. 2022 May 1;354:75-83. doi: 10.1016/j.ijcard.2022.02.012. Epub 2022 Feb 12.
PubMed 35167907
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Analysis of Myocardial Function by Speckle Tracking Echocardiography and Prediction of Delayed Toxic Cardiomyopathy Associated With Anthracycline Therapy in Children
- ClinicalTrials.gov ID
- NCT05781672
- Acronym / sponsor ID
- SpeckleAnthra2 / RECHMPL22_0513
- Conditions
- Cardiotoxicity, Childhood Cancer
- Keywords
- Echocardiography, Ventricular function, Stroke Volume
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Analyses will be performed with data from included patients until the end of the inclusion period. The clinical team did not wish to extend the inclusion period in order not to delay the analyses.
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 23 Mar 2023 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anthra2 | Experimental | Diagnostic Test: cardiac ultrasound with speckle tracking analysisPatient will have an echocardiography with speckle tracking analysis 5 years after the end of their participation to "SpeckleAnthra" study (NCT02893787) |
| Control | Active comparator | Diagnostic Test: cardiac ultrasound with speckle tracking analysisCardiac ultrasound analysis with speckle tracking of age- and sex-matched healthy patients in the Anthra2 group |
Who may qualify
- Ages
- 11 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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
- 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.
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 |
|---|---|---|
| cardiac ultrasound with speckle tracking analysisExperimental 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. | Diagnostic test | Anthra2, Control |
Primary outcome
Left Ventricle Global Longitudinal 2D strain (LVGLS) expressed in percentage and obtained from cardiac ultrasound cineloop of 2D 4,3 and 2 apical views analyzed by the Tomtec STE Software.
Time frame: 5 years
To compare the evolution at 5 years ("Anthra2" study timeframe) of LVGLS obtained by STE analysis on patients treated with anthracyclines in childhood and previously included in first "Speckle Anthra" study, with the normal evolution of this parameter with age in healthy matched volunteers.
3 secondary outcomes
Left Ventricle Ejection fraction (LVEF) by Simpson method (%)
Time frame: The day of inclusion
Left ventricular myocardial dysfunction defined by LVEF < 55%
Time frame: 5 years
Death secondary to toxic cardiomyopathy
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Analyses will be performed with data from included patients until the end of the inclusion period. The clinical team did not wish to extend the inclusion period in order not to delay the analyses.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Background: PubMed 35167907Amedro P, Vincenti M, Abassi H, Lanot N, De La Villeon G, Guillaumont S, Gamon L, Mura T, Lopez-Perrin K, Haouy S, Sirvent A, Cazorla O, Vergely L, Lacampagne A, Avesani M, Sirvent N, Saumet L. Use of speckle tracking echocardiography to detect late anthracycline-induced cardiotoxicity in childhood cancer: A prospective controlled cross-sectional study. Int J Cardiol. 2022 May 1;354:75-83. doi: 10.1016/j.ijcard.2022.02.012. Epub 2022 Feb 12.
- Individual participant dataSharing planned: Yes. sharing of results after obtaining
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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. This study is not recruiting at the moment.
VINCENTI Marie, PH principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiac ultrasound with speckle tracking analysis in people with Cardiotoxicity and Childhood Cancer, run by University Hospital, Montpellier at 1 site in France.
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 10 inclusion and 5 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: stopped early, as of the sponsor's last update on 19 Feb 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 France. 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?
The study was stopped early (reason given: Analyses will be performed with data from included patients until the end of the inclusion period. The clinical team did not wish to extend the inclusion period in order not to delay the analyses.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricle Global Longitudinal 2D strain (LVGLS) expressed in percentage and obtained from cardiac ultrasound cineloop of 2D 4,3 and 2 apical views analyzed by the Tomtec STE Software. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05781672, which also lists 1 linked publication.
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 19 Feb 2025.