Biomarkers in Blood and Bone Marrow Samples From Patients With Acute Lymphoblastic Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01284010
First received: January 25, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted

January 25, 2011
January 25, 2011
October 2010
December 2010   (final data collection date for primary outcome measure)
  • Correlation between alteration and gene, exon, and m-RNA expression with complete remission rate, disease-free survival, cumulative incidence of relapse, overall survival, and event-free survival [ Designated as safety issue: No ]
  • Associations between genome-wide DNA copy number alterations and outcome in adult ALL and comparison of these data with already generated pediatric ALL [ Designated as safety issue: No ]
Same as current
No Changes Posted
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Biomarkers in Blood and Bone Marrow Samples From Patients With Acute Lymphoblastic Leukemia
Genome-Wide Analysis of Genetic Alterations in Adult Acute Lymphoblastic Leukemia

RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in blood and bone marrow samples from patients with acute lymphoblastic leukemia.

OBJECTIVES:

  • To perform high-resolution, genome-wide profiling of DNA copy number alterations and loss-of-heterozygosity in samples from adult patients with acute lymphoblastic leukemia (ALL) obtained at diagnosis.
  • To perform candidate gene resequencing of diagnostic ALL samples.
  • To examine correlation of genetic alterations with outcome.
  • To examine the correlation between microarray multi-gene and multi-exon expression signatures with specific alterations and outcome.
  • To understand genetic events that contribute to the formation, development, and relapse of adult ALL by integrating the copy number and sequence alterations with the multi-gene signatures, and by comparing these data with data already generated in pediatric ALL.

OUTLINE: Diagnostic, complete remission, and germ-line specimens are analyzed for DNA profiling and gene resequencing by the Affymetrix SNP6.0 microarray platform, PCR, and fluorescence in situ hybridization (FISH). Frequency of genetic alterations are performed by the Agilent 2100 Bioanalyzer. Results are then compared with the data already generated from pediatric patients.

Observational
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Leukemia
  • Genetic: DNA analysis
  • Genetic: fluorescence in situ hybridization
  • Genetic: gene expression analysis
  • Genetic: microarray analysis
  • Genetic: mutation analysis
  • Genetic: polymerase chain reaction
  • 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.
 
Not yet recruiting
200
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December 2010   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • This is a multicenter study.
  • Diagnostic and germ-line specimens from patients with acute lymphoblastic leukemia (ALL) treated on protocols CALGB 9511, CALGB-19802, CALGB-10102, and CALGB-10403 and who have been registered on the companion study CALGB-9665 (The CALGB Leukemia Tissue Bank)

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Both
16 Years and older
No
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NCT01284010
CDR0000694150, CALGB-21001
Not Provided
Monica M. Bertagnolli, Cancer and Leukemia Group B
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Principal Investigator: James Downing, MD St. Jude Children's Research Hospital
National Cancer Institute (NCI)
January 2011

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