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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003933
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: October 2002

November 1, 1999
February 6, 2009
April 1999
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Complete list of historical versions of study NCT00003933 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
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Primary Purpose: Diagnostic
Leukemia
Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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DISEASE CHARACTERISTICS:

  • Diagnosis of acute lymphocytic leukemia and treated on protocol CCG-1941
  • Material cryopreserved in the CCG cell bank

PATIENT CHARACTERISTICS:

Age:

  • Children

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • See Disease Characteristics
Both
up to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada
 
NCT00003933
CDR0000067125, COG-B9805, CCG-B9805
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Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Stephen P. Hunger, MD University of Florida
National Cancer Institute (NCI)
October 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP