This clinical trial studies cancer survivors to identify those who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer. A patient's genes may affect the risk of developing complications, such as congestive heart failure, avascular necrosis, stroke, and second cancer, years after undergoing cancer treatment. Genetic studies may help doctors identify survivors of childhood cancer who are more likely to develop late complications.
PRIMARY OBJECTIVES: I. To identify key adverse events developing in patients (cases) with a primary cancer diagnosed at age 21 or younger. II. To characterize the key adverse events with respect to the nature of the primary malignancy (pathology, stage) and coded details of the therapeutic protocol. III. To identify treatment-related and demographic risk factors through a direct comparison of the case-group and controls identified from the remaining patients with the same primary diagnosis. IV. To compare the frequency of mutations or polymorphisms in specific candidate genes in cases and controls, using constitutional deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) from the cases and controls. V. To explore the role and nature of gene-environment interaction in the development of key adverse events. OUTLINE: DNA and RNA from peripheral blood or saliva sample of patients is analyzed for the presence of polymorphisms in genes associated with an increased risk of late-occurring complications.
Study Type
OBSERVATIONAL
Enrollment
3,885
Correlative studies
Ancillary studies
Rate of adverse events (cardiac dysfunction, AVN, ischemic stroke, and SMN using a matched case-control)
Epidemiological, clinical and laboratory variables will be tested for their association with key adverse events. McNemar's test for paired data will be used to compare the unmatched general characteristics of cases and controls.
Time frame: Up to 1 year
Frequency of mutations or polymorphisms in specific candidate genes in cases and controls
Allele frequencies will be estimated by the gene counting method, and the chi-square test will be used to check for departures from Hardy-Weinberg equilibrium.
Time frame: Up to 1 year
Crude disease-exposure
The crude disease-exposure association will be determined by estimating the OR and its 95% confidence interval (CI). This will be done by univariate conditional logistic regression, to account for the matched design. The significance of the OR will be assessed by the Wald test. Backward stepwise regression procedures will be used to develop the final multivariate model and possible interactions will be examined. The fit of the model will be assessed by the logistic regression diagnostics procedure.
Time frame: Up to 1 year
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Children's Hospital of Alabama
Birmingham, Alabama, United States
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Kaiser Permanente Downey Medical Center
Downey, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Mattel Children's Hospital UCLA
Los Angeles, California, United States
Valley Children's Hospital
Madera, California, United States
...and 146 more locations