NCT02893787

Brief Summary

The main goal of this study is to compare the values of echocardiographic parameters obtained by Speckle Traking analysis on myocardial function among patients under 18 years treated with anthracyclines in childhood, with healthy age and sex mached volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 14, 2022

Status Verified

February 1, 2022

Enrollment Period

1.5 years

First QC Date

August 5, 2016

Last Update Submit

February 25, 2022

Conditions

Myocardial FunctionEchographic Parameters Obtaind by Speckle TrackingChilhood Cancers

Keywords

Speckle TrackingAnthracyclinesChilhood cancersMyocardial functionEchocardiography

Outcome Measures

Primary Outcomes (1)

  • Echocardiographic parameters obtained by Speckle Tracking

    Immediat

Study Arms (2)

Patients treated with anthracyclines in childhood

Other: Speckle Tracking Echocardiography

Healthy volunteers

Other: Speckle Tracking Echocardiography

Interventions

Speckle Tracking EchocardiographyOTHER

Echocardiography analyses

Healthy volunteersPatients treated with anthracyclines in childhood

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients under 18 years treated with anthracyclines in childhood and healthy age and sex mached volunteers.

You may qualify if:

  • Patient treated between 0 and 18 with anthracyclines for malignancy
  • Discontinuation of treatment with chemotherapy for over 1 year
  • Patient in remission of his malignancy
  • Lack of heart or lung disease associated
  • No opposition patient and legal guardian
  • Patient younger than 18 at the time of the study.

You may not qualify if:

  • Progressive malignant pathology.
  • Cardiac, lung or muscle chronic diseases, etiology other than secondary to treatment with anthracyclines
  • Refusal to participate in the study
  • Poor echogenicity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Montpellier

Montpellier, 34295, France

Location

Related Publications (1)

  • 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.

    PMID: 35167907RESULT

Study Officials

  • Laure SAUMET, DR

    Hôpital Arnaud de Villeneuve

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2016

First Posted

September 9, 2016

Study Start

January 1, 2015

Primary Completion

July 1, 2016

Study Completion

January 1, 2017

Last Updated

March 14, 2022

Record last verified: 2022-02

Locations

FR(1)