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

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Leukemia

Treatments: Genetic: polymerase chain reaction; Genetic: fluorescence in situ hybridization; Other: laboratory biomarker analysis; Genetic: mutation analysis; Genetic: DNA analysis; Genetic: gene expression analysis; Genetic: microarray analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01284010

CDR0000694150 (Registry Identifier)

CALGB-21001

P30CA014236 (U.S. NIH Grant/Contract)

RC1CA145707 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

200 participants in 1 patient group

Group 1

Description:

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.

Treatment:

Genetic: polymerase chain reaction

Genetic: DNA analysis

Genetic: fluorescence in situ hybridization

Other: laboratory biomarker analysis

Genetic: gene expression analysis

Genetic: mutation analysis

Genetic: microarray analysis