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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01284010
Enrollment
200
Registered
2011-01-26
Start date
2011-02-28
Completion date
2014-09-30
Last updated
2020-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

adult acute lymphoblastic leukemia

Brief summary

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.

Detailed description

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.

Interventions

GENETICDNA analysis
GENETICfluorescence in situ hybridization
GENETICgene expression analysis
GENETICmicroarray analysis
GENETICmutation analysis
GENETICpolymerase chain reaction
OTHERlaboratory biomarker analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
complete remission rateUp to 7 Years
disease free survivalUp to 7 Years
cumulative incidence of relapseUp to 7 years
overall survivalUp to 7 years
event-free survivalUp to 7 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026