Cardiovascular Function in Adult Survivors of Childhood Malignancies

NCT ID: NCT01415999

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

142 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-07-31

Brief Summary

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Anthracyclines have been used commonly to treat children with solid tumours and haematological malignancies and have led to their increased survival. Nonetheless, anthracycline has the side effect of cardiotoxicity. The purpose of this study is to assess the impact of anthracycline therapy on heart deformation and fibrosis, heart-vessel interaction, usefulness of circulating biomarkers in the assessment of heart function and potential genetic predisposition to heart failure in adult survivors of childhood cancers.

Detailed Description

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Incorporation of anthracyclines into chemotherapy protocols has improved the survival of children with solid tumours and haematological malignancies. Nonetheless, longitudinal studies have implicated the absence of a safe anthracycline dose that is free of cardiotoxicity. Substantial risk for cardiovascular disease has been shown recently in large cohorts of adult survivors of childhood and adolescent survivors. Serial monitoring of cardiac function is hence of paramount importance in childhood cancer survivors for early detection of myocardial damage and timely institution of interventions. The optimal monitoring of cardiac function in the long term in these at-risk patients remains to be established. Novel noninvasive imaging modalities including echocardiography and cardiac magnetic resonance allow interrogation of myocardial deformation and fibrosis, while circulating biomarkers are increasingly used to monitor the cardiac status in heart failure patients. Additionally, genetics of heart failure are increasingly unveiled.

Conditions

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Childhood Cancers

Keywords

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anthracycline cardiac function echocardiography biomarkers

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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patient

adult survivors of childhood malignancies

No interventions assigned to this group

control

healthy age-matched individuals

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* patients aged 18 to 35 years old
* history of acute leukaemia diagnosed before 18 years old
* completion of cancer directed therapy for at least 5 years.

Exclusion Criteria

* history of congenital heart disease
* presence of syndromal disorder such as Down syndrome, neurofibromatosis, etc,
* hypothyroidism not on replacement therapy
* claustrophobia or other reasons rendering MRI assessment not feasible.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Professor Yiu-fai Cheung

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yiu-fai Cheung, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Queen Mary Hospital

Hong Kong, Hong Kong, China

Site Status

Countries

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China

Other Identifiers

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UW 11-289

Identifier Type: -

Identifier Source: org_study_id