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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01284010
First received: January 25, 2011
Last updated: July 23, 2015
Last verified: July 2015

January 25, 2011
July 23, 2015
February 2011
January 2100   (final data collection date for primary outcome measure)
  • complete remission rate [ Time Frame: Up to 7 Years ] [ Designated as safety issue: No ]
  • disease free survival [ Time Frame: Up to 7 Years ] [ Designated as safety issue: No ]
  • cumulative incidence of relapse [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • event-free survival [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • 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 ]
Complete list of historical versions of study NCT01284010 on ClinicalTrials.gov Archive Site
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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
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Non-Probability Sample

Acute lymphoblastic leukemia (ALL) patients treated on protocols CALGB 9511, 19802, 10001, 10102, and 10403, and who have been registered on the companion study CALGB 9665 (The CALGB Leukemia Tissue Bank)

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
Group 1
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.
Interventions:
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
Not Provided
January 2100   (final data collection date for primary outcome measure)

Inclusion:

• Diagnostic and germ-line specimens from patients with acute lymphoblastic leukemia (ALL) treated on protocols CALGB 9511, CALGB-19802, CALGB-10001, CALGB-10102, and CALGB-10403 and who have been registered on the companion study CALGB-9665 (The CALGB Leukemia Tissue Bank)

Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01284010
CALGB-21001, CALGB-21001, RC1CA145707, P30CA014236, CDR0000694150
No
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: James Downing, MD St. Jude Children's Research Hospital
Alliance for Clinical Trials in Oncology
July 2015

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