Study of Late-Occurring Complications in Childhood Cancer Survivors
Recruitment status was Recruiting
RATIONALE: A patient's genes may affect the risk of developing complications, such as congestive heart failure, heart attack, 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.
PURPOSE: This clinical trial is studying cancer survivors to identify those who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer.
Genetic: cytogenetic analysis
Genetic: mutation analysis
Genetic: polymorphism analysis
Other: questionnaire administration
|Official Title:||Key Adverse Events After Childhood Cancer|
|Study Start Date:||March 2004|
|Estimated Primary Completion Date:||March 2005 (Final data collection date for primary outcome measure)|
- Identify key late-occurring complications, specifically, cardiac dysfunction (closed to accrual as of 4/17/09), myocardial infarction (closed to accrual as of 6/5/06), ischemic stroke, avascular necrosis (closed to accrual as of 11/26/08), and subsequent malignant neoplasm, in childhood cancer survivors.
- Correlate key late-occurring complications with pathology and staging of the primary malignancy and therapeutic treatment protocol details in these patients.
- Identify treatment-related and demographic risk factors by comparing patients who develop late-occurring complications (case group) vs those with the same primary malignancy who do not develop late-occurring complications (control group).
- Compare the frequency of mutations or polymorphisms in specific candidate genes in both the case and control groups using constitutional DNA and RNA from both groups.
- Explore the role and nature of gene-environment interaction in the development of late-occurring complications in these patients.
OUTLINE: This is a multicenter study.
DNA from peripheral blood or buccal sample of patients is analyzed for the presence of polymorphisms in candidate genes associated with an increased risk of late-occurring complications, such as cardiac dysfunction (closed to accrual as of 4/17/09), myocardial infarction (closed to accrual as of 6/5/06), ischemic stroke, avascular necrosis (closed to accrual as of 11/26/08), and subsequent malignant neoplasms.
Patients also complete a questionnaire detailing family history and health history.
PROJECTED ACCRUAL: A total of 6,900 patients (1,725 with late-occurring complications [case group] and 5,175 without late-occurring complications [control group] [myocardial infarction patients closed to accrual as of 6/5/06, avascular necrosis patients closed to accrual as of 11/26/08, cardiac dysfunction patients closed to accrual as of 4/17/09]) will be accrued for this study.