NCT00003933

Diagnostic Study of Gene Alterations in Children Who Have Been Treated for Relapsed Acute Lymphocytic Leukemia

The Incidence and Prognostic Significance of P16 INK4A/ P15 INK4B Gene Alterations in Children With Relapsed ALL Treated on CCG-1941

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Leukemia

Interventions

Type	Name	Description
OTHER	laboratory biomarker analysis

Timeline

• Start date: 1999-04-01
• Primary completion: 2006-04-01
• First posted: 2003-05-02
• Last updated: 2014-08-07

Locations

41 sites across 3 countries: United States, Australia, Canada