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Cardiovascular Function in Adult Survivors of Childhood Malignancies

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01415999
First Posted: August 12, 2011
Last Update Posted: October 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Professor Yiu-fai Cheung, The University of Hong Kong
  Purpose
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.

Condition
Childhood Cancers

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Novel Imaging and Circulation Biomarkers for Comprehensive Evaluation of Cardiovascular Function in Adult Survivors of Childhood Malignancies

Further study details as provided by Professor Yiu-fai Cheung, The University of Hong Kong:

Biospecimen Retention:   Samples With DNA
plasma, serum

Enrollment: 142
Actual Study Start Date: August 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
patient
adult survivors of childhood malignancies
control
healthy age-matched individuals

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients will be recruited from the 5 public hospitals in Hong Kong (Prince of Wales Hospital, Princess Margaret Hospital, Queen Elizabeth Hospital, Queen Mary Hospital, and Tuen Mun Hospital) that treat the vast majority of childhood cancers, with the number of patients recruited from each hospital proportional to the respective new case-loads in the past 10 years.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01415999


Locations
China, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Yiu-fai Cheung, MD The University of Hong Kong
  More Information

Responsible Party: Professor Yiu-fai Cheung, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01415999     History of Changes
Other Study ID Numbers: UW 11-289
First Submitted: August 10, 2011
First Posted: August 12, 2011
Last Update Posted: October 25, 2017
Last Verified: October 2017

Keywords provided by Professor Yiu-fai Cheung, The University of Hong Kong:
anthracycline
cardiac function
echocardiography
biomarkers