Cardiovascular Function in Adult Survivors of Childhood Malignancies

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by The University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Professor Yiu-fai Cheung, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01415999
First received: August 10, 2011
Last updated: February 22, 2012
Last verified: February 2012
  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

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Biospecimen Retention:   Samples With DNA

plasma, serum


Estimated Enrollment: 150
Study Start Date: August 2011
Estimated Study Completion Date: July 2012
Estimated 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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415999

Contacts
Contact: Yiu-fai Cheung, MD 852-22554090 xfcheung@hkucc.hku.hk

Locations
China, Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong, China
Contact: Yiu-fai Cheung, MD    852-22554090    xfcheung@hkucc.hku.hk   
Principal Investigator: Yiu-fai Cheung, MD         
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Yiu-fai Cheung, MD The University of Hong Kong
  More Information

No publications provided

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
Study First Received: August 10, 2011
Last Updated: February 22, 2012
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
anthracycline
cardiac function
echocardiography
biomarkers

ClinicalTrials.gov processed this record on July 31, 2014