Cardiovascular Function in Adult Survivors of Childhood Malignancies
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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 |
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 |
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.
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| Contact: Yiu-fai Cheung, MD | 852-22554090 | xfcheung@hkucc.hku.hk |
| 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 | |
| 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 May 19, 2013