Diagnostic Study of Gene Alterations in Children Who Have Been Treated for Relapsed Acute Lymphocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT00003933|
Recruitment Status : Completed
First Posted : May 2, 2003
Last Update Posted : August 7, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Other: laboratory biomarker analysis||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|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|
|Actual Primary Completion Date :||April 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003933
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|Study Chair:||Stephen P. Hunger, MD||University of Florida|