Epidemiology of Cardiotoxicity in Children With Cancer

NCT ID: NCT00005418

Last Updated: 2016-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

1992-04-30

Study Completion Date

1994-03-31

Brief Summary

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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.

Detailed Description

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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.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Conditions

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Cardiovascular Diseases Heart Diseases Heart Failure, Congestive Death, Sudden, Cardiac Heart Failure

Eligibility Criteria

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Inclusion Criteria

No eligibility criteria
Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role lead

References

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Krischer JP, Epstein S, Cuthbertson DD, Goorin AM, Epstein ML, Lipshultz SE. Clinical cardiotoxicity following anthracycline treatment for childhood cancer: the Pediatric Oncology Group experience. J Clin Oncol. 1997 Apr;15(4):1544-52. doi: 10.1200/JCO.1997.15.4.1544.

Reference Type BACKGROUND
PMID: 9193351 (View on PubMed)

Other Identifiers

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R03HL048020

Identifier Type: NIH

Identifier Source: secondary_id

View Link

4336

Identifier Type: -

Identifier Source: org_study_id

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