Clinical trial NCT01284010: Biomarkers in Blood and Bone Marrow Samples From Patients With Acute Lymphoblastic Leukemia
Official title: Genome-Wide Analysis of Genetic Alterations in Adult Acute Lymphoblastic Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: adult acute lymphoblastic leukemia
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-01-26
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

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.

Eligibility 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)

Primary outcomes:
measure: complete remission rate
timeFrame: Up to 7 Years
measure: disease free survival
timeFrame: Up to 7 Years
measure: cumulative incidence of relapse
timeFrame: Up to 7 years
measure: overall survival
timeFrame: Up to 7 years
measure: event-free survival
timeFrame: Up to 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Cancer and Leukemia Group B
state: Illinois
Study officials:
affiliation: St. Jude Children's Research Hospital
name: James Downing, MD
role: STUDY_CHAIR
References: