Diagnostic Study of Gene Alterations in Children Who Have Been Treated for Relapsed Acute Lymphocytic Leukemia
RATIONALE: Diagnostic procedures, such as genetic testing, may improve the ability to detect acute lymphocytic leukemia and determine the extent of disease.
PURPOSE: Diagnostic study to try to detect changes in the genes of children who have been treated for relapsed acute lymphocytic leukemia.
|Study Design:||Primary Purpose: Diagnostic|
|Official Title:||The Incidence and Prognostic Significance of P16 INK4A/ P15 INK4B Gene Alterations in Children With Relapsed ALL Treated on CCG-1941|
|Study Start Date:||April 1999|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
- Determine the incidence of p16/p15 homozygous deletions and p15 promoter hypermethylation in acute lymphocytic leukemia cells of children treated on protocol CCG-1941.
- Determine the prognostic importance of p16/p15 abnormalities in these children.
- Determine the presence or absence of p16/p15 abnormalities in the dominant clone at diagnosis if present at relapse in these patients.
OUTLINE: Frozen cells are obtained from samples collected on protocol CCG-1941. DNA is isolated and examined using Southern blot analysis to assay for deletions and promoter hypermethylation of p16 and/or p15.
PROJECTED ACCRUAL: Approximately 100 samples will be obtained for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003933
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|Study Chair:||Stephen P. Hunger, MD||University of Florida|