Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005418
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2000-05-25
Brief Title:
Epidemiology of Cardiotoxicity in Children With Cancer
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To provide a comprehensive analysis of risk factors for the development of clinical cardiotoxicities in over 6000 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
Detailed Description:
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 andor 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
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
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 andor 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
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R03HL048020 | NIH | None | httpsreporternihgovquickSearchR03HL048020 |