Cardiovascular Function in Adult Survivors of Childhood Malignancies

October 24, 2017 updated by: Professor Yiu-fai Cheung, The University of Hong Kong

Novel Imaging and Circulation Biomarkers for Comprehensive Evaluation of Cardiovascular Function in Adult Survivors of Childhood Malignancies

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

142

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China
        • Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
patient
adult survivors of childhood malignancies
control
healthy age-matched individuals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Yiu-fai Cheung, MD, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2011

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

August 10, 2011

First Submitted That Met QC Criteria

August 11, 2011

First Posted (ESTIMATE)

August 12, 2011

Study Record Updates

Last Update Posted (ACTUAL)

October 25, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 11-289

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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