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Home > "E" Clinical Trials Conditions > Epidemiology of Cardiotoxicity in Children with Cancer  Epidemiology of Cardiotoxicity in Children with Cancer
Epidemiology of Cardiotoxicity in Children with Cancer
For Condition: Death, Sudden, Cardiac,Heart Failure, Congestive,Heart Diseases,Cardiovascular Diseases,Heart Failure
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To provide a comprehensive analysis of risk factors for the development of clinical cardiotoxicities in over 6,000 children with cancer who had been treated on standardized protocols involving the use of anthracyclines alone or in combination with other potentially cardiotoxic therapies or with no use of anthracycline therapy.
Details: DESIGN NARRATIVE: The data were analyzed to estimate the incidence of clinical cardiotoxicity as measured by sudden death, congestive heart failure, or discontinuation of therapy based on cardiac function. Evaluation of patient characteristics (age, anemia) and treatment factors such as drug, dose level, dosing schedule, exposure to irradiation and/or cyclophosphamide identified groups at particularly high risk for development of clinical cardiotoxicity and provided estimates of this risk for future treatment planning. Such estimates of high risk groups should make possible future trials to test the feasibility of using cardioprotectors or alternate dosing schedules to prevent cardiotoxicity. The incidence of clinical cardiotoxicity was calculated using Kaplan- Meier estimates as a function of total cumulative anthracycline dose and also as a function of the time since the end of treatment stratified by dose levels. The estimates were stratified by exposure to cyclophosphamide and radiation therapy. Multivariate methods were used to evaluate the prognostic significance of selected patient characteristics and treatment parameters and to provide estimates of the relative risk of each variable. The method of recursive partitioning was used to identify subpopulations at elevated risk for clinical cardiotoxicity. The data and analytic techniques were accessible through SAS data sets and procedures available to the study at the Pediatric Oncology Group (POG) Statistical Office.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: No eligibility criteria
Total Enrollment:
Location and Contact Information:
Additional Information:
Study ID Numbers: 4336;
Study Start Date: April 1992
Record last reviewed: September 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005418
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Epidemiology of Cardiotoxicity in Children with Cancer
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